# FDA 483 - Mentha & Allied Products Private Ltd. - September 25, 2024

Source: https://www.globalkeysolutions.net/records/483/mentha-allied-products-private-ltd/6a539459-0f97-4596-9175-51a1ceab4000

> FDA 483 for Mentha & Allied Products Private Ltd. on September 25, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Mentha & Allied Products Private Ltd.
- Inspection Date: 2024-09-25
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Mentha & Allied Products Private Limited received a Form 483 following an inspection that revealed significant deficiencies across multiple areas of its active pharmaceutical ingredient (API) manufacturing operations. Key issues include a dysfunctional Quality Unit, inadequate data integrity controls, poor complaint handling, insufficient personnel training, and failures in equipment validation, process validation, and material control. The observations highlight a systemic lack of adherence to cGMP principles, posing risks to product quality and regulatory compliance.

## Related Documents

- [WARNING_LETTER - 2024-09-25](https://www.globalkeysolutions.net/records/warning_letter/mentha-allied-products-private-ltd/cd89bb46-1c81-4864-9260-6f8c7799c438)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)
- [Chemist/Investigator - Pharmaceutical Quality](https://www.globalkeysolutions.net/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)

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

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8