Drugs

4 CGMP Violations in TCI Co Inspection

A 3/9-3/16 FDA inspection at the TCI Co., Ltd BioCosme PABP Branch drug manufacturing facility in Taipei City, Taiwan, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 9/2 Warning Letter says the four specific violations were:

failure 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, before release;
failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
failure to establish adequate written procedures for production and process controls designed to assure that drug products have the identity, strength, purity, and quality that they are purported or represented to possess; and
failure of the firm’s quality control unit to exercise its responsibility to ensure manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

FDA acknowledges the firm’s stated decision to allow its FDA drug registration to expire. The letter says that if TCI plans to resume any manufacturing activities, it is to contact the agency in advance. FDA recommends that the company retain a qualified consultant to perform a comprehensive six-system audit of its entire operation and assist it in meeting CGMP requirements.

TCI was told to promptly address the violations and ensure that appropriate resources are allocated to fully address the violations and prevent their recurrence.

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FDA Flags BD Alaris Infusion Sets Over Performance