Biologics

Multiple Violations in Amniotic Therapies Inspection

David McFarland

— 2 min read
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A 3/23-5/4 FDA inspection at Amniotic Therapies, Farmers Branch, TX, found multiple violations in the firm’s receiving of amniotic tissue recovered from cesarean births and processing the amnion, a structural tissue, from donors for allogenic use. The firm also produces AlphaGEMS, AlphaGEMS Micro and AlphaGEMS Nano products, the letter says.

FDA says the three named products are promoted to enhance tissue healing and repair and thus are considered drugs and biological products under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. They also are human cells, tissues, or cellular or tissue-based products but do not meet specified criteria to qualify for regulation solely under those regulations.

The letter says that those marketing a drug that is also a biological product must have a valid biologics license in effect. “The AlphaGEMS, AlphaGEMS Micro, and AlphaGEMS Nano products are not the subject of an approved BLA, nor are there INDs in effect for any of these products,” the letter says.

During the inspection, agency investigators also documented evidence of significant deviations from current good manufacturing practice in the manufacturing of the three named products, the letter says. Specific violations noted on an FDA-483 included: 

  •          failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
  •          failing to establish and follow 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;
  •          failing to establish and follow written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures;
  •          failing to maintain laboratory controls that include establishing scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
  •          failing to test the AlphaGEMS, AlphaGEMS Micro, and AlphaGEMS Nano products, non-penicillin drug products, for the presence of penicillin although a reasonable possibility exists that non-penicillin drug products have been exposed to cross-contamination with penicillin;
  •          failing to adequately validate the manufacturing process for the amnion intermediates for AlphaGEMS, AlphaGEMS Micro, and AlphaGEMS Nano;
  •          failing to validate a process change in the manufacturing of amnion intermediates for the three named products in response to reports of adverse reactions;
  •          failing to conduct environmental monitoring for the presence of microorganisms during the manufacture of the amnion intermediates for the three named products;
  •          failing to establish adequate written procedures describing the in-process controls and tests or examinations to be conducted on the amnion intermediates for the three named products to assure batch uniformity and integrity; and
  •          failing to establish and maintain adequate procedures for receiving, identifying, storing, handling, sampling, testing, and approving or rejecting specified supplies and components.

The company’s response did not provide sufficient detail to fully assess the adequacy of its corrective actions. The firm was told to take prompt action to correct the violations and to respond with a list of any additional steps it has taken or will take to correct the noted deviations and prevent their recurrence, along with documentation of each step and a timetable for completion.

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