# FDA 483 - Calvin Scott & Company, Inc. - March 12, 2020

Source: https://www.keypedia.com/records/483/calvin-scott-company-inc/e15766fc-98bb-4131-8185-f2bd51e18dec

> FDA 483 for Calvin Scott & Company, Inc. on March 12, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Calvin Scott & Company, Inc.
- Inspection Date: 2020-03-12
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Calvin Scott & Company, Inc. in Albuquerque, NM, a drug repackager and relabeler, was inspected by the FDA from March 9-12, 2020. The inspection revealed significant deficiencies across its quality system, facilities, equipment, and packaging/labeling controls, including a non-existent quality control unit, inadequate cleaning and maintenance, and lack of proper procedures for stability testing, change control, and deviation investigations. Several observations were repeats from a previous inspection, indicating persistent non-compliance.

## Related Documents

- [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)
- [483 - 2023-06-19](https://www.keypedia.com/records/483/calvin-scott-company-inc/4a36bfb4-17cc-4b1f-bec6-e2842ad360b5)

## Related Officers

- [Pharmaceutical Program Expert](https://www.keypedia.com/people/zachary-l-stamm/b729fab9-4d31-4c70-b5b3-e8b6207769c6)

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