Pharmedica CGMP Violations Result in Plant Shutdown

An 11/1-11/7/22 FDA inspection at the Pharmedica USA drug manufacturing facility in Phoenix, AZ, determined that drug products manufactured there are adulterated in that they have been prepared, packed, or held under insanitary conditions. As a result, the company said it would shut down all manufacturing and distribution. A 4/28 Warning Letter also says the inspection found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. Specific violations cited in the letter were:

• failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
• failing to perform operations within specifically defined areas of adequate size and having separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas;
• failing to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess;
• failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and to conduct for each batch of drug product appropriate laboratory testing, as necessary, required to be free of objectionable organisms;
• 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 your component supplier’s test analyses at appropriate intervals; 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 says that following a 2/2 teleconference with FDA, the firm indicated its commitment to cease the manufacturing and distribution of all drug products with no intention of producing drug products in the future, and agreed to voluntarily recall all drug products manufactured with MSM (methylsulfonylmethane).FDA says that if the company decides to resume any regulated operations it should contact the agency first and should engage a qualified consultant to assist it in meeting CGMP requirements.

Pharmedica was told to promptly correct violations and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.