# FDA 483 - Person & Covey Inc - January 30, 2020

Source: https://www.keypedia.com/records/483/person-covey-inc/5e871f8f-ea70-4609-a4c4-bb99d5fca383

> FDA 483 for Person & Covey Inc on January 30, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Person & Covey Inc
- Inspection Date: 2020-01-30
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Person & Covey Inc, a drug manufacturer in Glendale, CA, was inspected by the FDA from January 28-30, 2020, resulting in six observations. The inspection revealed significant deficiencies including the marketing of unapproved prescription drug products, inadequate container closure systems, and a complete lack of an active stability program. Further issues involved insufficient cleaning validation, an absent environmental monitoring program, and a failure to ensure executive review of internal investigations and FDA inspection reports.

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## Related Officers

- [Bryan L. Mcguckin](https://www.keypedia.com/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

Company: https://www.keypedia.com/companies/person-covey-inc/1d68fe99-fc79-460a-9c77-130fb16fc78e

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