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

Source: https://www.keypedia.com/records/483/apicore-pharmaceuticals-private-ltd/a54e66c6-dc71-4bfd-bd82-7ebfc5987398

> 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: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 was issued to Apicore Pharmaceuticals Private Ltd, a manufacturer located in Vadodara, Gujarat, India, following an inspection from April 27 to May 5, 2023. The inspection revealed two observations.

Observation 1 details inadequate validation of aseptic processes designed to prevent microbiological contamination of sterile drug products. Specifically, a media fill study (MF/CPMD/22/04/01) conducted in May 2021 for sterile API manufacturing failed, recovering multiple CFUs, including spore-forming bacteria (Bacillus subtilis, Bacillus pumilus, Bacillus oceanisediminis, Bacillus megaterium). Instead of performing three consecutive media fills for re-validation, the firm conducted only one repeat media fill. Additionally, the disinfectant efficacy study (Protocol #s ACP-22-015-00) used a method (pipetting disinfectant over dried culture) that differed from the routine disinfection procedure (spreading disinfectant with a mop or lint-free cloth per APV-SOP-MFG253).

Observation 2 notes that routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance. Specifically, analytical balance QCE # 684, used in the QC chemistry laboratory for weighing test samples with a range of 20 mg to 200 g, had its verification performed only for the 50 mg to 20

## Related Documents

- [483 - 2023-05-05](https://www.keypedia.com/records/483/apicore-pharmaceuticals-private-ltd/a1650a38-2f55-4071-8cfb-2041f1405a8d)

## 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/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c