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FDA issued a warning letter to contract testing laboratory, Adamson Analytical Laboratories, for CGMP violations.
FDA issued a warning letter to contract testing laboratory, Adamson Analytical Laboratories, on August 2, 2016 following an August 2015 inspection that discovered current good manufacturing practice (CGMP) violations at the company’s Corona, CA facility. The company was specifically cited for data integrity and quality testing issues.
The warning letter states that the company failed to exercise appropriate control over computer or related systems. FDA states in the letter that the company’s high-performance liquid chromatography (HPLC) and gas chromatography (GC) data acquisition systems did not adequately prevent potential deletion or alteration of raw data files. “During the inspection, our investigators observed that your laboratory personnel use a shared password to access the HPLC (b)(4) computer system and that your GC (b)(4) computer system requires no password for access,” FDA stated in the letter. There was also a lack of an audit trail function for recording analytical testing information such as type of injection, date and time, identity of analyst, and reason for action taken.
These observations were also seen in a February 2013 inspection of the facility. “In 2013, you committed to augmenting the security of your computer systems within six months. However, based on our 2015 inspection, it appears that you have not made appropriate corrective actions such as installing audit trails and ensuring that analysts have unique user names and passwords for your computerized systems,” FDA stated in the letter.
The company’s quality control unit also was cited for not establishing proper laboratory controls and failing to ensure materials were appropriately tested. FDA stated that the company’s quality control unit did not ensure that laboratory procedures, analytical data, or test results were complete and accurate. Specifically, the quality control unit did not detect inappropriately qualified reference standards, and HPLC data were missing from laboratory notebooks. FDA requested that the company provide a plan for how the quality control unit will perform its responsibilities.
“FDA considers contractors as extensions of the manufacturer’s own facility. Your failure to comply with CGMP may affect the quality, safety, and efficacy of the drugs you test for your clients. It is essential that you understand your responsibility to operate in full compliance with CGMP, and to inform all of your customers of significant problems or deviations encountered during the testing of these drugs,” the agency stated.