FDA EIR - Alcami Carolinas Corporation - March 28, 2017

An FDA inspection of Alcami Corporation's Affton, MO facility, a control testing laboratory for human and veterinary drug products, was conducted from March 22-28, 2017. The inspection, performed under current Good Manufacturing Practices (CGMP) for drug and animal drug manufacturing, identified two significant observations documented on an FDA Form 483. The primary issue concerned the improper storage of USP reference standards, with several instances found at room temperature despite requiring refrigeration, indicating a failure to adhere to established laboratory control mechanisms. For example, Chloroxylenol, Praziquantel, L-Phenylalanine, and Penicillin G Potassium standards were stored incorrectly. The second observation highlighted a data integrity concern, as time and date settings on certain laboratory equipment, including a Moisture Analyzer and two balances, were not restricted, allowing unauthorized changes by analysts. This violates requirements for appropriate controls over computer systems. Management, led by Site Director of Operations Ryan Williams, acknowledged the observations and committed to corrective actions. For the storage issue, Alcami initiated site-wide training on reference standard handling and updated their laboratory housekeeping checklist. Regarding equipment controls, two balances unable to restrict time/date settings would be replaced, and the Moisture Analyzer’s access would be restricted to authorized personnel. Alcami committed to a written response within 15 business days, addressing these findings.