# FDA 483 - Calvin Scott & Company, Inc. - June 19, 2023

Source: https://www.keypedia.com/records/483/calvin-scott-company-inc/4a36bfb4-17cc-4b1f-bec6-e2842ad360b5

> FDA 483 for Calvin Scott & Company, Inc. on June 19, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Calvin Scott & Company, Inc.
- Inspection Date: 2023-06-19
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Calvin Scott & Company, Inc. in Albuquerque, NM, a repackager and relabeler, received a Form 483 with five observations. The inspection revealed significant deficiencies in quality unit responsibilities, annual product review procedures, employee cGMP training, and equipment maintenance and qualification. Several observations were repeats from previous inspections, indicating persistent issues.

## Related Documents

- [483 - 2020-03-12](https://www.keypedia.com/records/483/calvin-scott-company-inc/e15766fc-98bb-4131-8185-f2bd51e18dec)
- [WARNING_LETTER - 2020-03-12](https://www.keypedia.com/records/warning_letter/calvin-scott-company-inc/94c46331-5a07-4a6d-a37a-806b9dbdeaec)
- [483 - 2021-06-18](https://www.keypedia.com/records/483/calvin-scott-company-inc/622f2373-45a1-484b-82c0-c260e904ea54)

## Related Officers

- [Cecilia H. Kieu](https://www.keypedia.com/people/cecilia-h-kieu/3ba5feb0-d49e-4301-ae5c-b84bd604a159)

Company: https://www.keypedia.com/companies/calvin-scott-company-inc/0e6b68ca-114f-4255-a8ed-f246bd0bae91

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face