FDA 483 - Element Materials Technology Boston - Acton Inc. - August 01, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
An FDA inspection of Element Materials Technology Boston - Acton, Inc. revealed significant deficiencies in its quality control unit and equipment logging practices. The firm failed to properly investigate environmental monitoring excursions and out-of-specification results, and its raw material control system was inadequate. Additionally, critical equipment logs for endotoxin testing lacked essential batch processing details, indicating a need for improved record-keeping and quality oversight.
- Inspection Date
- August 1, 2025
- Product Type
- Drugs
- Person
ID · dbe185a8-bf2e-4522-a8b1-a98b6ec9f219