# FDA WARNING_LETTER - Blaine Labs Inc - September 30, 2019

Source: https://www.globalkeysolutions.net/records/warning_letter/blaine-labs-inc/8d38c46f-25a9-47d5-9980-7ebe49c0fa06

> FDA WARNING_LETTER for Blaine Labs Inc on September 30, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Blaine Labs Inc
- Inspection Date: 2019-09-30
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA inspected Blaine Labs Inc. from September 25-30, 2019, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The firm also manufactures "RevitaDERM PSORIASIS Treatment," an unapproved new drug.

Key violations include:
1. **Inadequate OOS Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate OOS results for products like Terpenicol AFC 13% topical cream (viscosity), Tineacide Antifungal Cream 13% (stability, appearance, viscosity, assay), and a raw material (microbial contamination), leading to release of affected lots. A retrospective review of all invalidated OOS results and a comprehensive assessment of the investigation system are required.
2. **Lack of Process and Cleaning Validation (21 CFR 211.100(a)):** The firm failed to validate manufacturing processes for multiple drug products, qualify equipment, and validate cleaning processes. A detailed validation program, timeline for PPQ, and improved cleaning validation program are required.
3. **Inadequate Water System Monitoring (21 CFR 211.84(d)(6)):** The firm did not adequately monitor or validate its water system, which supplied water for drug products and equipment cleaning. A comprehensive remediation plan for the water system and a procedure for ongoing control are required.
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## Related Documents

- [483 - 2019-09-30](https://www.globalkeysolutions.net/records/483/blaine-labs-inc/a27ac23d-c804-447d-aa97-dc5b27136fff)
- [483 - 2021-08-24](https://www.globalkeysolutions.net/records/483/blaine-labs-inc/ed8c4ec5-3608-44f3-a36b-89c1bd716c9d)
- [483 - 2023-12-15](https://www.globalkeysolutions.net/records/483/blaine-labs-inc/b1bb20b9-80ff-4191-913c-8c61d3c832b7)

## Related Officers

- [Program Division Director](https://www.globalkeysolutions.net/people/steven-e-porter/5448db0e-32f0-4e98-8a5f-9f0857373b06)

Company: https://www.globalkeysolutions.net/companies/blaine-labs-inc/9b08b501-8f11-452d-914e-3f5339cbed81

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