483
Element Materials Technology Oakland-ConcordElement Materials Technology Oakland-Concord – FDA 483, Dec 21, 2018
Record Details
Microbiology & Quality Associates LLC, a contract laboratory in Concord, CA, received a Form 483 with three observations. The inspection revealed failures in following quality control procedures for sample transport and temperature monitoring, inadequate employee training for critical equipment certification, and a lack of calibration for Biological Safety Cabinet pressure gauges. These issues indicate significant deficiencies in quality system adherence and personnel qualification.
- Inspection date
- December 21, 2018
- Product type
- other
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ID · ec1cb8e7-5ff4-446a-9ff2-eb0b90dc2b11
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