# FDA 483 - McKenna Labs Inc - March 05, 2020

Source: https://www.globalkeysolutions.net/records/483/mckenna-labs-inc/32371179-3cdc-4a14-b252-8918ed63e497

> FDA 483 for McKenna Labs Inc on March 05, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: McKenna Labs Inc
- Inspection Date: 2020-03-05
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

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Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6