483
Element Materials Technology Boston - Acton Inc.FDA 483 - Element Materials Technology Boston - Acton Inc. - January 15, 2019
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.
Record Details
Microbiology Research Associates, Inc., a control testing laboratory in Acton, MA, was cited for failing to follow established laboratory control mechanisms. Specifically, the firm did not initiate an out-of-specification investigation or notify a client when a drug sample failed endotoxin testing specifications. This indicates a lapse in quality control procedures for drug product testing.
- Inspection Date
- January 15, 2019
- Product Type
- Drugs
Open in Dashboard
ID · 4203cdbb-e0fc-4fa3-9b12-5f9e7470e84d