FDA EIR - Almac Pharma Services LLC - February 03, 2022

An FDA Pre-Approval Inspection of Almac Pharma Services LLC in Audubon, PA, was conducted from January 19 to February 3, 2022. The inspection, guided by CPGM 7346.832, assessed the firm's readiness for commercial manufacturing linked to new ANDA and NDA applications, and included a follow-up on prior records requests. The inspection revealed two primary objectionable conditions, documented on a 2-item FDA Form 483.

First, the company failed to thoroughly investigate unexplained discrepancies. Specifically, recurrent incidents of blister packaging machine jams leading to burst gel capsules, impacting potential product quality, were logged as maintenance issues but not subjected to formal deviation investigations, violating 21 CFR 211.192. This equipment is crucial for packaging the pre-approval products.

Second, Almac Pharma Services LLC inadequately addressed a persistent issue of water leaks through the ceiling into manufacturing rooms, corridors, and the warehouse. Despite numerous past occurrences dating to 2018, corrective actions focused on superficial repairs (e.g., ceiling tiles) rather than comprehensive solutions for the identified root causes, such as roof and Air Handling Unit problems.

Management committed to submitting a written response to the FDA-483 observations within 15 business days.