# FDA WARNING_LETTER - Monarch PCM, LLC - August 20, 2021

Source: https://www.keypedia.com/records/warning_letter/monarch-pcm-llc/4c4d52f4-8239-48e7-b083-cca2959d1604

> FDA WARNING_LETTER for Monarch PCM, LLC on August 20, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Monarch PCM, LLC
- Inspection Date: 2021-08-20
- Product Type: Drugs
- Office Name: Office of Pharmaceutical Quality Operations Division I
- Summary: The FDA inspected Monarch PCM, LLC from June 7 to August 20, 2021, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. The firm manufactures Hydroquinone USP, 4% Skin Bleaching Cream, Sodium Sulfacetamide 10% Wash, Sodium Sulfacetamide 10% and Sulfur 5% Cleanser, and Selenium Sulfide 2.25% Shampoo, which are cited as unapproved new drugs. Additionally, Hydroquinone USP 4% Skin Bleaching Cream and Selenium Sulfide 2.25% Shampoo are not properly listed with the FDA, making them misbranded.

Key violations include:
1. **Inadequate Investigations (21 CFR 211.192):** Failure to thoroughly investigate out-of-specification (OOS) results for drug components and finished products, including microbial contamination (Burkholderia cepacia complex - BCC). Investigations were insufficient, often invalidating OOS results based on retesting without scientific justification, and failing to implement adequate corrective and preventive actions (CAPAs).
2. **Inappropriate Equipment Design and Maintenance (21 CFR 211.63):** Water systems and manufacturing equipment are not designed, cleaned, or maintained appropriately, contributing to persistent objectionable microorganism findings.
3. **Quality Control Unit Failures (21 CFR 211.22):** The Quality Unit

## Related Documents

- [EIR - 2018-02-06](https://www.keypedia.com/records/eir/monarch-pcm-llc/8f640c0c-957f-4029-8b89-659e78cb80a2)
- [483 - 2018-02-06](https://www.keypedia.com/records/483/monarch-pcm-llc/fb2ba290-6480-40a9-9455-e9d1a3b184a4)
- [483 - 2021-08-20](https://www.keypedia.com/records/483/monarch-pcm-llc/a99481c5-4df3-44c2-a5c4-c20b3fedbfee)

## Related Officers

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

Company: https://www.keypedia.com/companies/monarch-pcm-llc/ee588fdf-02dc-4629-9dee-c06da9214f78

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality-operations-division-i/798d6a62-d1f1-4f7c-8de3-465e277c13da