FDA EIR - AJES Pharmaceuticals, LLC - March 29, 2018

An FDA inspection of AJES Pharmaceuticals LLC, a dietary supplement contract manufacturer located in Copiague, NY, was conducted from March 8-29, 2018. This inspection served as a follow-up to a 2016 Warning Letter and previous "Official Action Indicated" classification, which stemmed from significant manufacturing deficiencies, including the firm's involvement in manufacturing a product containing an unapproved new drug, leading to a voluntary recall.

The 2018 inspection, conducted under the regulatory framework of Compliance Program 7321.008 for Dietary Supplements (21 CFR Part 111), revealed persistent violations of Current Good Manufacturing Practices (cGMP). The main issues cited on the FDA Form 483 included the firm's failure to verify that finished batches of dietary supplements met product specifications for identity, purity, strength, and composition (a repeat observation). Additionally, AJES Pharmaceuticals did not establish clear identity specifications for each component or provide documented scientific rationale for how in-process and component specifications collectively ensure the finished dietary supplement meets all required specifications.

Management, represented by Vice President Asha Patel, acknowledged the observations and committed to submitting a written response to the FDA Form 483 within 15 business days. Further verbal observations discussed included the need to address cracked floor tiles, update the pest control Standard Operating Procedure, and comprehensively review all existing SOPs, many of which had not been revised since 2009.