483
McKenna Labs IncFDA 483 - McKenna Labs Inc - March 05, 2020
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
McKenna Labs Inc, a drug product manufacturer in Fullerton, CA, was inspected by the FDA from March 2-5, 2020. The inspection revealed significant deficiencies across laboratory controls, quality control unit procedures, employee training, and manufacturing records. Key issues included incomplete laboratory data, unwritten and unfollowed QC procedures, inadequately trained personnel, and incomplete master and batch production records.
Open in Dashboard
ID · 32371179-3cdc-4a14-b252-8918ed63e497