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

Source: https://www.keypedia.com/records/warning_letter/calvin-scott-company-inc/94c46331-5a07-4a6d-a37a-806b9dbdeaec

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

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## Details

- Record Type: WARNING_LETTER
- Company Name: Calvin Scott & Company, Inc.
- Inspection Date: 2020-03-12
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA inspected Calvin Scott and Company Inc.'s drug manufacturing facility in Albuquerque, New Mexico, from March 9-12, 2020, identifying significant CGMP violations, rendering their drug products adulterated.

Key violations include:
1.  **Lack of Stability Data (21 CFR 211.137(a)):** The firm repackaged drug products, like hydrochlorothiazide tablets, into non-equivalent container-closure systems (heat-sealed pouches with one transparent side) without supporting stability data for assigned expiration dates. The FDA found their response inadequate as it didn't address moisture/oxygen transmission or container-product compatibility, and lacked a stability protocol/data. Corrective actions require a comprehensive stability program assessment, CAPA plan, stability-indicating methods, ongoing studies, and detailed procedures.
2.  **Inadequate Cleaning Procedures (21 CFR 211.67(b)):** The firm used non-dedicated repackaging lines without cleaning validation studies to prevent cross-contamination. Their response, acknowledging no cleaning validation, was deemed inadequate for not demonstrating cleaning program effectiveness. Required actions include a comprehensive cleaning program assessment and CAPA plan, improvements to cleaning effectiveness, enhanced ongoing verification, and a robust cleaning validation program addressing worst-case scenarios.
3.  **Deficient Quality Control Unit (21 CFR 211.22(a)):** The firm lacked an independent Quality Unit

## Related Documents

- [483 - 2020-03-12](https://www.keypedia.com/records/483/calvin-scott-company-inc/e15766fc-98bb-4131-8185-f2bd51e18dec)
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- [483 - 2023-06-19](https://www.keypedia.com/records/483/calvin-scott-company-inc/4a36bfb4-17cc-4b1f-bec6-e2842ad360b5)

## Related Officers

- [Ms.](https://www.keypedia.com/people/rachel-c-martin/4c23e2cf-06c0-4032-b34b-3e3b48df6749)
- [Director of Investigations Branch](https://www.keypedia.com/people/katherine-e-jacobitz/9a713b44-95c4-43a2-83bb-8d30062d8345)

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

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