AllerQuest LLC – FDA Warning Letter, Mar 1, 2019

The FDA issued a Warning Letter to AllerQuest LLC following an inspection from January 31 to March 1, 2019, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Facility Design and Control (21 CFR 211.42(c)):** The sterile injectable drug manufacturing facility's ISO 5 critical area directly interfaces with double doors having substantial gaps, posing a contamination risk from unclassified air. The aseptic processing line design is inadequate, with limited protection and high exposure to contamination. The firm's response regarding third-party consultants and sterility testing was deemed insufficient. 2. **Failure to Control Aseptic Processing Areas (21 CFR 211.42(c)(10)):** The firm failed to adequately address environmental control departures, including Bacillus sp. in the ISO 5 area, and used non-sporicidal agents for disinfection. Environmental and personnel monitoring programs were inadequate, with uninvestigated excursions and incorrect action limits for fingertip sampling. The firm lacked a continuous monitoring system for temperature, humidity, and pressure, leading to uninvestigated excursions. 3. **Inadequate Investigation of Discrepancies (21 CFR 211.192):** The firm failed to thoroughly investigate recurrent foreign particulate matter contamination in sterile injectable drug products, despite thousands of ampules failing specifications and