Drugs

CGMP Violations at Allay Pharmaceuticals

A 5/10-5/15/20 FDA inspection at Allay Pharmaceuticals, Hialeah, FL, found significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals. A 1/27 Warning Letter also says an unidentified tablet product is adulterated for failing to conform to compendial standards for strength, quality, or purity. FDA says the firm’s products are intended to treat a disease or condition and thus are defined as drugs and as biological products because they are a protein or analogous to a protein.

The letter says specific violations were:

failing to establish adequate written procedures for production and process control designed to assure that the drug products Allay manufactures have the identity, strength, quality, and purity they purport or are represented to possess;
failing to thoroughly investigate any unexplained discrepancy or 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 establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates; and
failure of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP, and meet established specifications for identity, strength, quality, and purity.

The letter notes that Allay is distributing a biological product without FDA approval or a valid BLA. The firm was told to contact the agency’s unapproved drugs coordinator for assistance in communicating with FDA on the application process for the unapproved biological product.

The letter also discusses Allay’s responsibilities as a contractor to ensure that its drugs are made following the law on safety, identity, strength, quality, and purity.

FDA recommended that the company retain a qualified third-party consultant to assist it in meeting CGMP requirements.

Allay was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the actions.

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