# FDA 483 - Chemeca Drugs Private Limited - March 10, 2021

Source: https://www.keypedia.com/records/483/chemeca-drugs-private-limited/e7fac1cf-fec7-4c69-beca-860ca4950e3d

> FDA 483 for Chemeca Drugs Private Limited on March 10, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chemeca Drugs Private Limited
- Inspection Date: 2021-03-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Chemeca Drugs Private Limited, an API manufacturer in Visakhapatnam, India, was cited for significant deficiencies in its quality unit procedures, laboratory investigations, and equipment cleaning and storage practices. Observations included inadequate retesting protocols, failure to investigate system suitability failures, insufficient cleaning validation, and contaminated production equipment. These issues indicate a lack of robust quality control and manufacturing process oversight.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.keypedia.com/companies/chemeca-drugs-private-limited/34e19502-dfc5-4e8d-9f16-4e0969be6c29

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