FDA 483 - Imprimis NJOF, LLC - January 29, 2021

This FDA Form 483 document details multiple observations from an inspection of an outsourcing facility. The facility failed to thoroughly review unexplained discrepancies or batch failures, including instances where personnel monitoring revealed microbial action limit excursions after critical interventions on sterile products.

Significant deficiencies in the quality system were noted, including the absence of written procedures for production and process controls to assure drug product identity, strength, quality, and purity. Procedures to prevent microbiological contamination of sterile drug products were not established. The quality control unit lacked the authority to reject in-process materials and drug products. Written procedures for cleaning schedules, methods, equipment, and materials for sanitation were also absent.

Laboratory controls did not include scientifically sound sampling plans. The facility compounded drug products withdrawn or removed from the market due to safety or effectiveness concerns, and compounded drugs essentially copied from approved drugs. Records were not maintained to evaluate drug product quality standards or determine the need for changes in specifications or procedures.

Furthermore, the outsourcing facility failed to submit adverse event reports to FDA as required by 21 CFR 310.305 and did not submit reports identifying drugs compounded during previous six-month periods. The facility also compounded drug products using bulk drug substances not on the drug shortage list or FDA's clinical need list, which is not permissible under section 503B.