FDA EIR - Nitro Quimica Corporation dba Alchemix A Nitro Quimica Corporation - February 14, 2019

An FDA inspection of Alchemix Corporation, a drug product manufacturer in College Park, GA, was conducted from February 8-14, 2019. This routine cGMP surveillance inspection, performed under FDA Compliance Policy Manual 7356.002 for Drug Manufacturing Inspections, identified several significant deficiencies. A six-item Form FDA 483, Inspectional Observations, was issued to the General Manager.

Main violations included the failure to maintain facility buildings in a clean, sanitary condition and good state of repair, evidenced by persistent standing water, bird feces, and a wall opening potentially allowing pest ingress. A pharmaceutical pump, crucial for product handling, was found uncleaned, uncovered, and lacked proper cleaning procedures and validation. Laboratory controls were deemed insufficient, stemming from the use of an expired reagent for cleaning verification, an incomplete stability chamber validation study, pre-dated laboratory results in batch records, and a lack of secondary verification for the stability chamber thermometer. Furthermore, the company lacked essential written procedures for managing non-conformances and for equipment usage and cleaning logs. Finally, batch production records were incomplete, missing dates for significant processing and packaging steps.

Management acknowledged the observations and committed to submitting a written response to the FDA 483 within 15 days, outlining proposed corrective actions. These actions include addressing safety concerns with facility conditions, installing protective screens, repairing building infrastructure, procuring new reagents, re-validating cleaning processes, implementing preventative measures for laboratory data integrity, and ensuring comprehensive batch record documentation.