# FDA WARNING_LETTER - Monarch Labs, LLC - June 14, 2010

Source: https://www.keypedia.com/records/warning_letter/monarch-labs-llc/fec0ed75-4467-4bca-b396-9e837c9536ab

> FDA WARNING_LETTER for Monarch Labs, LLC on June 14, 2010. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Monarch Labs, LLC
- Inspection Date: 2010-06-14
- Product Type: Devices
- Office Name: Los Angeles District Office
- Summary: On November 9, 2010, the FDA issued a Warning Letter to Monarch Labs, LLC, following an inspection from June 3-14, 2010. The inspection revealed that the firm's Medical Maggots and Maggot Confinement Dressings, classified as devices, were adulterated under 21 U.S.C. 35l(h) due to non-conformity with Current Good Manufacturing Practice (cGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included:
1.  **Failure to validate processes:** Sterilization and disinfection processes for fly eggs and device components were not validated, and weekly spore testing on the autoclave was not conducted (21 CFR 820.75(a)).
2.  **Inadequate CAPA procedures:** Investigation into non-conformities (e.g., contaminated culture media) lacked root cause determination and proper disposition of non-conforming product (21 CFR 820.100(a)(2)).
3.  **Insufficient non-conforming product control:** Procedures for identifying, documenting, evaluating, segregating, and disposing of non-conforming product were inadequate (21 CFR 820.90(a)).
4.  **Lack of supplier controls:** No established procedures for evaluating and qualifying suppliers, vendors, and contractors,

## Related Officers

- [Director](https://www.keypedia.com/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)

Company: https://www.keypedia.com/companies/monarch-labs-llc/d37ee57f-0673-4fe4-9632-ee76b79bb3eb

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b