FDA 483 - Somerville Acquisitions, Inc. - June 04, 2025

Somerville Acquisitions, Inc. in Flemington, NJ, an API manufacturing facility, received 11 observations during an FDA inspection from May 23 to June 4, 2025. The observations primarily concern significant deficiencies in process validation, equipment qualification, cleaning validation, raw material testing and vendor qualification, stability testing, and record-keeping for their USP grade Aluminum Chlorohydrate Solution API, which is manufactured for export to Columbia. Additionally, facility maintenance issues were noted.