483
Element Materials Technology Boston - Acton Inc.Element Materials Technology Boston - Acton Inc. – FDA 483, Jan 15, 2019
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
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ID · 4203cdbb-e0fc-4fa3-9b12-5f9e7470e84d
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