FRONTIER BIOLOGICS is back in the news, this time the DALLAS MORNING NEWS, yep. Seems Christopher Sin Los Huevos, our reporter at the Trib, isn’t interested in real news, our MCSO, well, Daddy Par got his vanity lights from Jay Justice so they’re marked “safe” for life, and our stereotypical DEI hire Police Chief just won’t do a damn thing to Frontier Biologics, or Lillie Hefele, whose murderer walks among us. Nope, she’d rather write some dumb shit children’s book while kids get heroin over at the Heroin Park on the Eastside, same place for years and years. No, she just wants to sit, not make waves, pretend to be doing something and hope no one notices how there is no law enforcement leadership in the entire town. How about Justice for Johnnie Sharp? No, too busy writing a kid’s book. JEEEEEEEeeezuschristwhatdoes it take here.
Anyway, below is the Dallas Morning News article about what a piece of illegal ca ca Frontier Biologics is and Waco law enforcement and media will continue to ignore it.
Well, we won’t.
H
KWTX News 10
Waco Police Chief Sheryl Victorian wrote her first children’s book, ‘The Me I See,’ to inspire kids to recognize they have the ability to become a police officer one day.
MORE INFO: https://www.kwtx.com/…/waco-police-chief-writes-first…/
FDA spars with Waco company over ‘unapproved’ and ‘unlicensed’ human amniotic products
Frontier Biologics says it’s breaking new ground, but the government thinks it’s breaking laws.
Health Reporter
Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that its manufacturing process violates safety regulations.
The U.S. Food & Drug Administration sent a warning letter to Frontier Biologics in November, outlining concerns about the company’s operations.
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But Frontier Biologics chief scientist Gene Elliott pushed back against that characterization, telling The Dallas Morning News that the FDA’s approach is too “white or black.” He argued the agency is painting the company as a bad actor for what he described as mostly mild and documentation-related violations.
“We agree with some of the information that was there,” Elliott said. But “there is no medium range there, there is no gray area.”
The Frontier Biologics website describes the company as a producer of “regenerative medicine therapies.” Regenerative medicine is a broad and far-reaching field, according to Andrew McMahon, a research professor at Caltech, who focuses on regenerative medicine and the kidney.
The field includes “anything that we can do that’s going to improve and restore organ function and stop degeneration of organ activities,”McMahon said.
When done with the appropriate supervision and approval, regenerative medicine can use bone marrow transplants to help patients with cancer or gene editing therapies and treat patients with genetic deficiencies.
Elliott said Frontier Biologics produces two products: an allograft patch, which is made from amniotic material and can be used to treat open wounds such as diabetic ulcers, and a fluid product that can be injected into the joints.
The company’s website itself, though, doesn’t describe the products specifically, focusing instead on Frontier Biologics’ vision of itself and its work. A video on the website’s homepage opens with a sweeping view of snow-covered trees. The narrator talks in a soft twang about pioneers and adventurers, over top of video clips of a bison, a covered wagon, astronauts and dancing robots.
Frontier Biologics is among these “brave leaders of a new frontier,” pushing the boundaries of medicine, the video narrator says.
Regulations
The FDA has been cracking down on some of the easiest-to-spot violators of manufacturing and marketing regulations in the regenerative medicine field, McMahon said.
According to him, based on the limited information publicly available, Frontier Biologics appears to fall into that easy-to-spot category.
The FDA’s warning focuses on two different issues. One is that birth-related products are considered drugs, meaning they’re subject to strict regulations and scrutiny.
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Companies have to receive a green light from the FDA before marketing and selling such products. According to the FDA warning letter, Frontier Biologics does not have such permission, meaning that its products are “unapproved new drugs” and “unlicensed biological products.”
Second, birth-related medical products must be produced under strictly controlled and sterile conditions. Frontier Biologics did not meet those standards, according to the letter.
But Elliott‚ the company’s chief scientist, insisted the company goes “above and beyond” on safety standards.
He also argued the FDA should not have categorized Frontier Biologics as a “stem cell” company, although the term “stem cell” does not appear in the publicly available version of the warning letter. Elliott argued there should be another regulatory category created that differentiates “biologics” more distinctly from “drugs.”
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It’s a change that Frontier Biologics hopes might come to pass under the new administration in Washington, Elliott said.
“We are a human cell- and tissue-based production facility,” Elliott said. “We were never set up to be a pharmacological company.”
‘Patients at risk’
The FDA’s regulations are designed to keep people safe and to keep companies in check.
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Paul Knoepfler, a stem cell researcher and professor at the University of California -Davis School of Medicine, said warning letters such as the one sent to Frontier Biologics are “one of the strongest steps that the FDA can take.”
As an example of just how wrong things can go when companies don’t follow federal rules, Knoepfler pointed to a case in California.
Liveyon and sister company Genetech manufactured and distributed injectable products made from human umbilical cord blood. The companies marketed the drugs as a treatment for a variety of diseases, including Alzheimer’s and Parkinson’s.
In addition to not being approved for medical use, some products were also contaminated with bacteria.
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A dozen users were eventually hospitalized with infections, according to media reports from 2018. The founder of the two companies, California resident John W. Kosolcharoen, pleaded guilty to federal charges last year.
In cases where products are not contaminated, substandard manufacturing processes might instead result in products that simply don’t work, Knoepfler said.
The FDA has posted a consumer notice about regenerative medicine products, noting there are no stem cell-based products approved to treat Alzheimer’s, Parkinson’s, heart diseases, lung diseases or COVID-19 complications.
“FDA is concerned that many patients seeking cures and remedies may be misled by information about products that are illegally marketed,” the agency writes. Citing “significant” concerns about safety and efficacy, the FDA says that they could “put patients at risk.”
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However, Frontier Biologics’ Elliot said the company does not market its products for any specific use or therapy.
While he doesn’t agree with the FDA’s warning letter to Frontier Biologics, Elliott added the company is doing everything it can to cooperate with the agency and to bolster safety standards.
“We want to be a leader in compliance and regulatory with the FDA,” Elliott said. “We feel like we’re above and beyond what the normal FDA is requiring” for human tissue-based products.
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- Frontier Biologics, LLC – 686059 – 11/01/2024
WARNING LETTER
Frontier Biologics, LLCMARCS-CMS 686059 —
Delivery Method:VIA EMAIL AND UNITED PARCEL SERVICEReference #:CBER 25-686059Product:Biologics
Drugs
Recipient:
Chad W. Justice
President/FounderFrontier Biologics, LLC
720 Jewell DriveWaco, TX 76712United States Chad@FrontierBiologics.comIssuing Office:Center for Biologics Evaluation and Research
United States
WARNING LETTER
November 1, 2024
CBER 25-686059
Dear Mr. Justice:
The United States Food and Drug Administration (FDA) inspected your facility, located at the above address between February 27, 2024, and March 8, 2024. During the inspection, FDA documented that your company manufactures a human amniotic fluid derived product, (b)(4), as well as a human amniotic membrane derived product, (b)(4), for allogeneic use (collectively, “your products”).1
This letter is to advise you that your products are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your products are also unlicensed biological products in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1). A biological product for which a biologics license application (BLA) has been approved under section 351(a) of the PHS Act is not required to have an approved application under section 505 of the FD&C Act, 21 U.S.C. § 355; 42 U.S.C. § 262(j). Otherwise, with certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act. Your introduction or delivery for introduction of your products into interstate commerce, or the causing thereof, is prohibited under sections 301(d) of the FD&C Act, 21 U.S.C. § 331(d).
This warning letter also summarizes significant violations of current good manufacturing practice (CGMP) requirements, including violations of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B), and 21 CFR parts 210 and 211. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding drugs do not conform to CGMP, your products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B). Your introduction or delivery for introduction of your products into interstate commerce, or the causing thereof, is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. § 331(a).
Unapproved New Drug and Unlicensed Biological Product Violations
Based on information and records reviewed by FDA, your products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or are intended to affect the structure or function of the body. For example, your products are intended for (b)(4), as evidenced by the following statements in materials collected during the inspection:
- “(b)(4).”
- “(b)(4) Applications [include]:
o (b)(4)
- “(b)(4)…Benefits:
o (b)(4)
- “(b)(4)…Use:
o (b)(4)
Therefore, your products are drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).2
Your (b)(4) product is also a human cell, tissue, or cellular or tissue-based product (HCT/P) as defined in 21 CFR 1271.3(d) and is subject to regulation under 21 CFR part 1271, issued under the authority of section 361 of the PHS Act, 42 U.S.C. § 264. HCT/Ps that do not meet all the criteria in 21 CFR 1271.10(a) are not regulated solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271. Unless an exception in 21 CFR 1271.15 applies, such products are regulated as drugs, devices, and/or biological products under the FD&C Act and/or the PHS Act and are subject to additional regulation, including applicable premarket review. Based on a review of relevant materials, your company does not qualify for any exception in 21 CFR 1271.15, and your product fails to meet all criteria in 21 CFR 1271.10(a).
For example, your (b)(4) product fails to meet the criterion that the HCT/Ps be “intended for homologous use only,” which means that the “labeling, advertising, or other indications of the manufacturer’s objective intent” demonstrate that the HCT/P is intended to perform “the same basic function or functions in the recipient as in the donor.” 21 CFR 1271.3(c) and 1271.10(a)(2). Your product is not intended solely to perform the same basic function or functions of the HCT/P in the recipient as in the donor (e.g., serving as a barrier for amniotic membrane). Rather, your product is intended for use in (b)(4), which is not a basic function of amniotic membrane in the donor.
Therefore, this HCT/P is not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.3 See 21 CFR 1271.20. In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your product is regulated as a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i), as stated above.
Subject to certain exceptions not applicable here, to lawfully introduce or deliver for introduction into interstate commerce a drug that is a biological product, a valid BLA must be in effect under section 351(a)(1) of the PHS Act, 42 U.S.C. § 262(a)(1). Such licenses are issued only after showing that the product is safe, pure, and potent. Your products are not the subject of an approved BLA.
CGMP Violations
FDA’s inspection of your facility documented evidence of significant CGMP violations. At the conclusion of the inspection, FDA investigators issued a Form FDA-483, List of Inspectional Observations (Form FDA-483).
The CGMP violations applicable to your products include, but are not limited to, the following:
1. Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes, as required by 21 CFR 211.113(b). For example, you failed to adequately validate (i.e., by performing media fill simulations) the aseptic process used to manufacture your (b)(4) product. Your product purports to be sterile and is expected to be sterile.
2. Failure to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess, as required by 21 CFR 211.100(a). Specifically,
a. The manufacturing process for your (b)(4) product has not been adequately validated with respect to identity, strength, quality, and purity. During the inspection, you provided a validation study for your amniotic fluid product, which only tested for sterility. However, this is not sufficient to assure the identity, strength, quality, and purity of your product.
b. The manufacturing process for your (b)(4) product has not been validated with respect to identity, strength, quality, and purity.
3. Aseptic processing areas are deficient regarding the system for environmental monitoring to prevent contamination, as required by 21 CFR 211.42(c)(10)(iv). For example, you have not performed non-viable particulate monitoring, personnel monitoring, active or passive viable air sampling, or sampling of critical surfaces for microorganisms in the aseptic processing area in association with each production batch.
4. Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions, as required by 21 CFR 211.42(c)(10)(v). For example, you have not validated your process for cleaning and disinfecting the ISO (b)(4) cleanrooms where your products are manufactured.
5. Written records are not always made of investigations into unexplained discrepancies or the failure of a batch or any of its components to meet specifications whether or not the batch has already been distributed , as required by 21 CFR 211.192. For example, from March 2023 and June 2023, your firm had two sterility failures during finished product testing of your (b)(4) product. Although you identified the contaminating organisms, you failed to conduct an investigation to determine the root cause of the failures.
6. Failure to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates, as required by 21 CFR 211.166(a). Specifically, you assigned a (b)(4) expiration date to your products without supporting data.
Response to the Form FDA-483
We have reviewed your response, dated March 28, 2024, to FDA’s Form FDA-483 in detail. Your response is inadequate because it did not provide sufficient detail for FDA to fully assess the adequacy of your corrective actions. It lacks documentation to demonstrate that you have corrected your violations and fails to include a timeline for completion of all necessary corrective actions. For example, in your response, you note that going forward, any (b)(4) still in house from previously opened lots will be discarded. However, your response does not address the (b)(4), which are used as packaging for your finished amniotic fluid products, that are (b)(4) using a sterilization process that has not been validated. Please be advised that in accordance with 21 CFR 211.113(b), you are required to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of sterilization processes.
Your response also does not address your specific plans for disposition of the inventory of (b)(4) or (b)(4) at your facility that were manufactured under the conditions described in this letter. Further, your response does not address products that have been distributed and remain in the marketplace.
We acknowledge your commitment to voluntarily suspend production activities until you have made corrections to the observations listed on the Form FDA-483. However, your response does not adequately address your failure to have an IND in effect to study your products addressed in this letter or your lack of an approved BLA to lawfully market your products. As noted above, to lawfully market a drug that is a biological product, a valid biologics license must be in effect. 42 U.S.C. 262(a). Such licenses are issued only after showing that the product is safe, pure, and potent. While in the development stage, such a product may be distributed for clinical use in humans only if the sponsor has an IND in effect for that product, as specified by FDA regulations, that covers such clinical use. 21 U.S.C. 355(i); 42 U.S.C. 262(a)(3); 21 CFR Part 312.
Conclusion
Neither this letter nor the observations noted on the Form FDA-483, which were discussed with you at the conclusion of the inspection are intended to be an all-inclusive list of deficiencies that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure full compliance with all applicable requirements in the FD&C Act, PHS Act, and all applicable regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in action without further notice, including, without limitation, seizure and/or injunction.
We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence. Include any documentation necessary to show that the matters have been addressed. If you cannot address these matters within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion. If you do not believe your products are in violation of the FD&C Act, PHS Act, or applicable regulations, include your reasoning and any supporting information for our consideration.
Send your electronic response to CBERDCMRecommendations@fda.hhs.gov. If you have questions regarding this letter, contact the Division of Case Management, CBER at (240) 402-9156.
Sincerely,
/S/
Melissa J. Mendoza
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
___________________
1 At the time of the inspection, FDA collected evidence that your human amniotic fluid derived product is also referred to as “Evexcell™ (b)(4)”. FDA also collected evidence that your human amniotic membrane derived product is also referred to as “(b)(4).”
2 We note that your amniotic fluid product, (b)(4), is not an HCT/P because amniotic fluid is a secreted bodily fluid and the definition of HCT/Ps in 21 CFR 1271.3(d)(3) excludes secreted or extracted human products.
3 Because your product fails to meet at least one criterion in 21 CFR 1271.10(a), this letter does not evaluate all other criteria in 21 CFR 1271.10(a).
