Drugs

Analytical Food Laboratories CGMP Violations

A 5/17-5/17 FDA inspection at the Analytical Food Laboratories contract testing laboratory in Grand Prairie, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 10/10 Warning Letter says specific violations were:

failure to establish and follow required laboratory control mechanisms, and to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; 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 FDA considers contractors as extensions of the manufacturer’s facility and thus a failure to comply with CGMP may affect the quality, safety, and efficacy of the drugs being tested for clients. “It is essential that you understand your responsibility to operate in full compliance with CGMP, and that you inform all your customers of any out-of-specification results or significant problems encountered during the testing of these days,” FDA says.

The agency recommends that Analytical engage a qualified consultant to assist it in meeting CGMP requirements.

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

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