# FDA WARNING_LETTER - Dextrum Laboratories Inc. - July 18, 2023

Source: https://www.keypedia.com/records/warning_letter/dextrum-laboratories-inc/70960935-81af-49dc-99ae-c3a2ca512f89

> FDA WARNING_LETTER for Dextrum Laboratories Inc. on July 18, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Dextrum Laboratories Inc.
- Inspection Date: 2023-07-18
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations II
- Summary: The FDA issued a Warning Letter to Dextrum Laboratories Inc. following an inspection from July 10-18, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include:
1.  **Failure to conduct identity testing for drug product components (21 CFR 211.84(d)(1)):** The firm, a contract manufacturer of OTC cough and cold products, did not adequately test each component lot, including active pharmaceutical ingredients like dextromethorphan, and high-risk components like glycerin, for identity and hazardous impurities such as diethylene glycol (DEG) or ethylene glycol (EG). Their response, proposing periodic third-party testing, was deemed inadequate as it lacked commitment to testing each lot and a retrospective review of previously used materials.
2.  **Failure to conduct microbiological testing of components with potential for objectionable contamination (21 CFR 211.84(d)(6)):** The firm failed to adequately monitor the microbiological quality of their (b)(4) water used in manufacturing, only testing on a (b)(4) basis, despite identifying dead legs in their water system.
3.  **Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a)):** The firm did not adequately validate production and process controls for their OTC drug products,

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## Related Officers

- [Director of Compliance Branch](https://www.keypedia.com/people/ronda-r-lloyd-jones/1446ba41-f1f2-4d40-8902-021b2bef3a53)

Company: https://www.keypedia.com/companies/dextrum-laboratories-inc/1de70261-362f-45f3-b0d3-19292a4eb0f4

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-ii/930d696b-0ac7-4de4-8268-e3db00525bc6