# FDA 483 - Apicore Pharmaceuticals Private Ltd - May 05, 2023

Source: https://www.keypedia.com/records/483/apicore-pharmaceuticals-private-ltd/a1650a38-2f55-4071-8cfb-2041f1405a8d

> FDA 483 for Apicore Pharmaceuticals Private Ltd on May 05, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apicore Pharmaceuticals Private Ltd
- Inspection Date: 2023-05-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Apicore Pharmaceuticals Private Ltd in Vadodara, India, identified critical deficiencies in their manufacturing operations. The firm failed to adequately validate its aseptic process for sterile drug products, including issues with media fills and disinfectant efficacy studies. Additionally, routine calibration of electronic equipment was not performed according to a written program, indicating a lack of proper quality control.

## Related Documents

- [483 - 2023-05-05](https://www.keypedia.com/records/483/apicore-pharmaceuticals-private-ltd/a54e66c6-dc71-4bfd-bd82-7ebfc5987398)

## Related Officers

- [Bijoy Panicker](https://www.keypedia.com/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

Company: https://www.keypedia.com/companies/apicore-pharmaceuticals-private-ltd/c91652e8-564d-4fbc-aff9-9f6ebd395cc4

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