# FDA WARNING_LETTER - Beauty Manufacturing Solutions Corp. - June 30, 2017

Source: https://www.keypedia.com/records/warning_letter/beauty-manufacturing-solutions-corp/2083ddae-00bb-49a0-b9e1-4663115031a2

> FDA WARNING_LETTER for Beauty Manufacturing Solutions Corp. on June 30, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Beauty Manufacturing Solutions Corp.
- Inspection Date: 2017-06-30
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA inspected Beauty Manufacturing Solutions Corp. from June 19-30, 2017, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The firm's July 24, 2017, response was deemed inadequate.

Violations include:
1.  **Failure to investigate discrepancies (21 CFR 211.192):** The firm failed to investigate water system test results showing microorganism levels "too numerous to count" (TNTC) on 25 of 96 days, despite using this water as a major component in OTC drug products and having written procedures requiring investigation for results above (b)(4) cfu/mL. The water system is considered fundamentally flawed. The firm's response, citing bulk product tests meeting specifications, was inadequate as it didn't address the investigation failure or commit to a comprehensive system redesign and ongoing control program to meet USP purified water specifications and appropriate microbial limits.
    *   **Required Actions:** Provide a comprehensive water system evaluation and CAPA, an effective ongoing control program ensuring USP purified water quality, a detailed risk assessment of affected drug product lots (prioritizing TNTC days, extending to all potentially affected lots), and a thorough assessment of overall investigation systems, including enhanced quality unit oversight.

2.  **Inadequate laboratory controls (21 CFR 211.160(b)):** Microbiological test

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## Related Officers

- [Program Division Director](https://www.keypedia.com/people/monica-r-maxwell/e1b3373a-80b0-4023-9aea-b4ac7170c964)

Company: https://www.keypedia.com/companies/beauty-manufacturing-solutions-corp/08a59977-bbec-43d4-a6cd-f4ee0d6ca7aa

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9