Drugs

CGMP Violations at Health Pharma

A 5/13-6/3/19 FDA inspection at the Health Pharma drug manufacturing facility in Rahway, NJ, found significant violations of current good manufacturing practice (CGMP) regulations. A 12/18/19 Warning Letter says specific violations were:

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;
failing to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced;
failing to establish adequate written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess and failure of the firm’s quality control unit to review and approve the procedures, including any changes; and
failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failing to validate and establish the reliability of component supplier’s test analyses at appropriate intervals.

The letter reminds the company that it is responsible for the quality of drugs it produces as a contract facility regardless of agreements in place with product owners. The letter also says the firm’s quality systems are inadequate and recommends that it engage a qualified consultant to assist it in meeting CGMP requirements.

Health Pharma was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion of the corrective actions.

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