Associates of Cape Cod, Inc. – FDA EIR, Nov 26, 2019

Associates of Cape Cod, Inc. underwent an FDA inspection from November 19 to November 26, 2019, as part of a Drug Process Inspection (Compliance Program 7356.002). The company operates as a contract testing laboratory and manufacturer of endotoxin and glucan detection products, regulated by CBER and CDRH, meaning they are subject to Current Good Manufacturing Practices (cGMP). The inspection identified two main violations, detailed in a Form FDA 483.

The first observation cited a consistent failure in laboratory record-keeping, specifically the inability to retain all raw data documentation. Examples included missing Reagents and Materials forms and original endotoxin testing printouts, with some documents inadvertently shredded. This was identified as a systemic issue involving multiple analysts and a lack of adequate preventative measures, violating 21 CFR 211.194(a)(4). The second observation noted that the Quality Unit failed to adequately review and close investigations, such as customer complaints and internal quality events, within the company's own established timeframes or procedures, without documented justification for these delays, violating 21 CFR 211.22(d).

Company management acknowledged the observations and committed to submitting a written response to the Agency within 15 business days. Additionally, a discussion highlighted the need for periodic re-qualification of temperature-controlled storage units used for critical reagents and samples, as continuous single-point monitoring alone is insufficient to demonstrate temperature uniformity.