# FDA 483 - Sharp Mint Limited - January 31, 2020

Source: https://www.keypedia.com/records/483/sharp-mint-limited/f256e212-2761-4ac0-9b50-52388e07650b

> FDA 483 for Sharp Mint Limited on January 31, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sharp Mint Limited
- Inspection Date: 2020-01-31
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: During an inspection of Sharp Mint Limited, an Active Pharmaceutical Ingredient (API) manufacturer in Delhi, FDA investigators observed significant deficiencies in the firm's quality and laboratory systems. Issues included a lack of an ongoing stability testing program, inadequate evaluation of procedural changes, and failures in testing incoming packaging materials and employee GMP training. Additionally, the firm failed to appropriately verify analytical methods and qualify reference standards for API release.

## Related Officers

- [Lata C. Mathew](https://www.keypedia.com/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)

Company: https://www.keypedia.com/companies/sharp-mint-limited/996e6827-d752-4b11-8918-67b95c7810dd

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1