Drugs

BioLab Sciences Illegally Selling Products: FDA

David McFarland

— 2 min read
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An 8/23-9/3/21 FDA inspection at BioLab Sciences, Scottsdale, AZ, found the company manufactures products derived from human amniotic fluid for allogenic use and an epidermal skin tissue product for autologous use. An 8/23 Warning Letter says BioLab has distributed the products to third-party distributors, some under private label, as well as directly to healthcare professionals throughout the U.S.

The letter says the firm’s products are legally defined as drugs and biological products and are subject to regulation. It says the investigators found that none of the firm’s products have an approved IND or BLA in effect and thus are being marketed illegally.

The inspection also found these significant CGMP deviations:

  • failing to establish appropriate written procedures to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes;
  • failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
  • failing to establish and follow written procedures for cleaning and maintenance of equipment used in the manufacture, processing, packing, or labeling of a drug product;
  • failing to establish and follow written procedures describing in sufficient detail the methods and materials used for sanitation;
  • the aseptic processing areas are deficiently designed in that the floors are not smooth, hard surfaces that are easily cleanable to prevent contamination;
  • failing to thoroughly investigate any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed;
  • failing to ensure that each lot of components, drug product containers, and closures are withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for sale by the quality control unit;
  • failing to establish written procedures for production and process controls to assure that drug products have the identity, strength, quality, and purity they purport or are represented to possess; and
  • failing to establish and follow a written testing program to assess the stability characteristics of drug products and to use the results of such stability testing to determine appropriate storage conditions and expiration dates.

The letter says the firm’s responses to the form FDA-483 issued following the inspection are inadequate to address the agency’s concerns.

BioLab was told to respond with a list of specific steps it has taken or plans to take to correct the noted violations and prevent their recurrence, with appropriate documentation and a schedule for completing the corrections.

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