# FDA WARNING_LETTER - Mentha & Allied Products Private Ltd. - September 25, 2024

Source: https://www.globalkeysolutions.net/records/warning_letter/mentha-allied-products-private-ltd/cd89bb46-1c81-4864-9260-6f8c7799c438

> FDA WARNING_LETTER for Mentha & Allied Products Private Ltd. on September 25, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Mentha & Allied Products Private Ltd.
- Inspection Date: 2024-09-25
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Mentha & Allied Products Private Ltd. following a September 16-25, 2024, inspection of their Rampur, India facility, identifying significant CGMP deviations for active pharmaceutical ingredients (APIs), rendering their API adulterated. The December 10, 2024, response was deemed inadequate.

Key violations include:
1.  **Facility Conditions:** Poor maintenance, soiled washroom, lack of hand soap, dirty gowning room, and visibly soiled cloth gloves for direct product contact without cleaning documentation.
2.  **Equipment Cleaning & Maintenance:** Inadequate procedures, "cleaned" equipment found deficient, lack of documented and validated cleaning procedures (e.g., solvent use, critical steps, specific microbial sampling locations), and insufficient cleaning records.
3.  **Quality Unit Failures & Data Integrity:** Torn batch records and chromatograms, uncontrolled labeling, non-contemporaneous documentation with backfilling from uncontrolled sheets, and inadequate electronic data controls (e.g., corrupted hard drive for Agilent OpenLab CDS data backup, lack of thorough investigation into data loss).
4.  **Material System Deficiencies:** Failure to identity test each batch of incoming raw materials, reliance on unqualified supplier COAs, and lack of supplier qualification for critical raw materials.
5.  **Inadequate API Testing & Method Validation:** Failure to test (b)(4) USP (b)(4) API

## Related Documents

- [483 - 2024-09-25](https://www.globalkeysolutions.net/records/483/mentha-allied-products-private-ltd/6a539459-0f97-4596-9175-51a1ceab4000)

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.globalkeysolutions.net/companies/mentha-allied-products-private-ltd/a04f0178-87e0-4e57-8f95-964a0553cb9f

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c