# FDA 483 - Continental Manufacturing Chemist, Inc. - May 10, 2023

Source: https://www.keypedia.com/records/483/continental-manufacturing-chemist-inc/c01c4a4e-d60c-4f57-8f11-cea08c3ec1da

> FDA 483 for Continental Manufacturing Chemist, Inc. on May 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Continental Manufacturing Chemist, Inc.
- Inspection Date: 2023-05-10
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Continental Manufacturing Chemist, Inc. in Madrid, IA, an OTC and animal drug product manufacturer, was cited for significant quality control deficiencies during an FDA inspection. Observations included a failure to perform adequate identity testing for incoming components and active pharmaceutical ingredients, a lack of appropriate laboratory determination of identity and strength for active ingredients in finished drug products prior to release, and the absence of established cleaning validation procedures for non-dedicated equipment to prevent cross-contamination. These issues indicate a systemic breakdown in ensuring product quality and safety.

## Related Documents

- [WARNING_LETTER - 2017-04-28](https://www.keypedia.com/records/warning_letter/continental-manufacturing-chemist-inc/33387a82-10da-45af-a9a7-e500d1b1caa6)
- [483 - 2019-07-30](https://www.keypedia.com/records/483/continental-manufacturing-chemist-inc/2216f624-ca27-4c06-a65c-679ade817c50)

## Related Officers

- [Torrey M. Ward](https://www.keypedia.com/people/torrey-m-ward/e3021951-811e-45a0-a029-69c7cc862fcf)

Company: https://www.keypedia.com/companies/continental-manufacturing-chemist-inc/dbd35050-6757-4c52-845d-f37426a80a57

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8