Drugs

CGMP Violations at Adamson Analytical Labs

A 3/8-3/23 FDA inspection at Adamson Analytical Laboratories, Corona, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals in the company’s work as a contract testing laboratory for prescription and over-the-counter finished drug products and active pharmaceutical ingredients. A just-released 8/17 Warning Letter says specific violations were:

failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records; and
failing to establish and follow required laboratory control mechanisms.

The letter says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it tests. FDA recommends that the firm retain a qualified consultant to assist it in remediation.

The agency also recommends a consultant to assist Adamson in meeting CGMP requirements since the company failed to correct repeat violations.

The letter says the firm’s responses to the inspection observations were inadequate because they did not offer sufficient detail or evidence of corrective actions to lead to CGMP compliance.

FDA also reminds Adamson of its responsibility as a contract testing lab to operate in full compliance with CGMP and inform all its customers of any out-of-specification results or significant problems encountered during the testing of drugs.

Adamson was told to correct the violations promptly and to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence and a timetable for completing the corrections.

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