FDA EIR - Strem Chemicals, Inc. - January 27, 2020

Strem Chemicals, Inc. in Newburyport, MA, underwent an FDA inspection from January 21-27, 2020. This comprehensive inspection, part of the OPQO Division I Work-plan, focused on the firm's manufacturing of Active Pharmaceutical Ingredients (APIs), including Cisplatin USP and Dexmedetomidine Hydrochloride USP. The inspection was conducted under Compliance Programs 7356.002L (API Process Inspection) and 7371.001 (Animal Drug Manufacturing Inspections), adhering to 21 CFR 211 and ICH Q7 guidelines.

Significantly, no formal Form FDA 483 Inspectional Observations was issued at the conclusion of this inspection, indicating a generally compliant state. The inspection also verified satisfactory corrections to five observations from a previous 2017 inspection related to investigation procedures, environmental monitoring, Quality Unit adherence, raw material control, and training.

Despite no formal observations, the inspection report highlighted several areas for discussion and potential improvement with management. These included the lack of scientific justification for the placement of a temperature/humidity probe in the GMP Raw Materials storage room, the observation of cracked and flaking paint within a production hood in the API Intermediates manufacturing area posing a potential contamination risk, and the absence of lot numbers or expiry dates for cleaning agents on cleaning checklists. Management acknowledged these points, indicating areas for voluntary enhancement. No refusals were encountered, and no samples were collected during the inspection.