FDA WARNING_LETTER - Amresco LLC - December 18, 2012

An FDA inspection of Amresco LLC, a contract manufacturer of in-vitro diagnostic kit reagents, from October 15 to December 18, 2012, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated.

Key violations include:

1. **Failure to adequately validate processes (21 CFR 820.75(a)):** * Mixing instructions for Reagent A and B lacked quantified time ranges and validated speeds (e.g., "allow to mix until dissolved," unvalidated 50%-70% speed, unvalidated 15-60 minute mixing time). * Out-of-specification (OOS) pH results for Reagent A were crossed out without investigation. * Ten of fifteen OOS cap torque results for Reagent B were accepted without investigation or corrective action. * The automated line filling system's capping operation was not validated, with high OOS torque removal rates (82-88%) observed in device history records. The firm's response to implement containment and revalidate processes is noted.

2. **Failure to establish and maintain procedures for analyzing quality data (21 CFR 820.100(a)(1)):** Rejected/reworked materials (e.g., for labeling, capping, fill volume, leaking