Warning Letters 07/26/20: Testing into Compliance

This week, the FDA posted two warning letters to firms that sold cord blood products without having an active IND or approved BLA. There were also two warning letters posted to the manufacturers of OTC drug products. 

Along with the usual collection of warning letters regarding COVID related products or devices, FDA posted seven warning letters to firms that were distributing unapproved products labeled as dietary supplements for the treatment of hangovers. FDA expressed concern that “Consumers may get the false impression that using these products can prevent or mitigate health problems caused by excessive drinking. Dietary supplements are not a substitute for responsibly limiting one’s alcohol consumption.” We do not cover these here. 

Drug Warning and Untitled Letters

American Medical Aesthetics and Regenerative Medicine Inc

American Medical Aesthetics and Regenerative Medicine Inc (Irvine, CA) received an untitled letter on July 22, 2020, based on a review of advertising on their website. The firm distributes umbilical cord-derived cellular products that they claim treat a variety of diseases and conditions including autism, multiple sclerosis, liver disease, heart disease, and lupus. FDA states that these products appear to be human cell, tissue, or tissue-based products (see 21CFR 1271). These products need to be supported by an IND or a BLA, neither of which are in place.

21st Century LaserMed Pain Institute

21st Century LaserMed Pain Institute d/b/a/ Cerate Wellness Clinics (Garden Grove, CA) received a warning letter on July 21, 2020, based on a review of the firm’s website and Youtube videos. The firm offers umbilical cord-derived stem cell products to treat COVID-19 infections. The product is deemed an unapproved new drug and is also misbranded. This product is also an unlicensed biological product and is not supported by an IND or BLA. The product appears to be a HCT/P that is regulated by FDA. They also market for a variety of conditions, also these products are regulated and require premarket review and approval.  

Eosera, Inc.

Eosera, Inc (Fort Worth, TX) received a warning letter on July 13, 2020, based on the outcome of an inspection ending January 17, 2020. The firm manufactures OTC drug products. A collection of these is unapproved of new products. FDA recommends the firm hire qualified consultants to assist them in coming into GMP compliance.

Deficiencies include but are not limited to:

• OOS results were not adequately investigated. The firm instructed the contract lab to retest after a failing microbiological result rather than conduct an investigation. The firm used the passing re-test result to approve the release of the lot. Investigations, when finally conducted, did not determine the root cause and scope of product failures. Nor were the investigations extended to all lots manufactured with the questionable water.

• The stability program is inadequate. The firm changed specifications after the first test result failed, thus allowing failing lots to meet the newly revised specifications.

• The firm did not validate the manufacturing process, stating it was similar enough to another product that it did not require it’s own validation effort. Further, one process was not revalidated when the manufacture was moved to a new facility. FDA points out that they don’t comply with the FDA’s guidance on process validation.

• The Quality Unit did not have adequate procedures, documentation, and practices to exercise its functions.

Tender Corporation

Tender Corporation (Littleton, NH) received a warning letter on July 23, 2020, based on the outcome of an inspection ending November 25, 2019. The firm manufactures and distributes OTC products. The FDA recommends they hire a qualified consultant to assist them in coming into GMP compliance. FDA also states that “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.” 

Further, the FDA cited similar observations during an inspection in May 2016 and June 2018. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.” And finally, the firm was distributing unapproved new drugs that are also misbranded.

Deficiencies include but are not limited to:

• The analytical record did not accurately represent all testing performed. Some HPLC injections were not included in test results. The IR instrument system did not have adequate access controls and data could be deleted or altered by analysts. Employees also shared a common log-in password to access the system.  

• The firm did not have scientifically sound procedures for testing of APIs. The firm’s method resulted in abnormal peaks, missing integration, and required blank injections between samples to prevent carryover.

Device Warning and Untitled Letters

No letters were issued this week. 

Letters to Compounding Pharmacies and Outsourcing Facilities

No letters were issued this week. 

BIMO, GCP and GLP Warning and Untitled Letters

No letters were issued this week.