# FDA 483 - Calvin Scott & Company, Inc. - June 18, 2021

Source: https://www.globalkeysolutions.net/records/483/calvin-scott-company-inc/622f2373-45a1-484b-82c0-c260e904ea54

> FDA 483 for Calvin Scott & Company, Inc. on June 18, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Calvin Scott & Company, Inc.
- Inspection Date: 2021-06-18
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Calvin Scott & Company, Inc. in Albuquerque, NM, a drug repacker and relabeler, received a Form 483 with seven observations, including several repeat observations from a previous inspection. The inspection revealed significant deficiencies in quality control, equipment qualification, employee training, facility sanitation, and process validation. These issues indicate a lack of adherence to cGMP requirements for drug product repackaging, posing potential risks to product quality and patient safety.

## Related Documents

- [483 - 2020-03-12](https://www.globalkeysolutions.net/records/483/calvin-scott-company-inc/e15766fc-98bb-4131-8185-f2bd51e18dec)
- [WARNING_LETTER - 2020-03-12](https://www.globalkeysolutions.net/records/warning_letter/calvin-scott-company-inc/94c46331-5a07-4a6d-a37a-806b9dbdeaec)
- [483 - 2023-06-19](https://www.globalkeysolutions.net/records/483/calvin-scott-company-inc/4a36bfb4-17cc-4b1f-bec6-e2842ad360b5)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/dustin-m-james/bf423ddc-721b-4049-9eb1-3bc0fdb44441)
- [Scott N. Lim](https://www.globalkeysolutions.net/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

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

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