# FDA 483 - Apitoria Pharma Private Limited - September 27, 2024

Source: https://www.keypedia.com/records/483/apitoria-pharma-private-limited/d70a197d-94fc-49c8-88c7-eb078a386f9f

> FDA 483 for Apitoria Pharma Private Limited on September 27, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apitoria Pharma Private Limited
- Inspection Date: 2024-09-27
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 was issued to Apitoria Pharma Private Limited, an API (Active Pharmaceutical Ingredient) manufacturer located in Sanga Reddy District, Telangana, India, following an inspection from September 23-27, 2024. The report, issued to Sridhar Smat, Associate Vice President Operations, details ten observations related to manufacturing and quality control deficiencies.

Key observations include:
1.  **Equipment Upkeep:** Manufacturing equipment showed visible scratch marks, dents, and white residue/stains on product-contact surfaces, indicating inadequate cleaning and maintenance. Preventive maintenance checklists did not include checks for these issues.
2.  **Manufacturing Instructions:** Production records lacked adequate manufacturing instructions, specifically regarding visual checks by operators and the inclusion of variable parameters for equipment operation. Cleaning records for product change-over and periodic cleaning did not include instructions or documentation for visual inspection checks.
3.  **Training Deficiencies:** Personnel were not adequately trained on swab sampling for cleaning verification or on assessing microbial growth in growth promotion tests.
4.  **Quality Unit Review:** The quality unit failed to adequately review and approve quality-related documents, specifically a change control for a reduced batch size API, leading to discrepancies in batch record checklists.
5.  **Water System and Sampling:** The water system design was inadequate, with an unprotected open-environment tank for solution preparation. Water sampling demonstrations showed improper technique, including contamination risks and leaking connectors.
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## Related Documents

- [483 - 2016-07-01](https://www.keypedia.com/records/483/apitoria-pharma-private-limited/6f2a3f13-62ed-4024-b141-70e9668fa578)
- [483 - 2019-10-25](https://www.keypedia.com/records/483/apitoria-pharma-private-limited/d9f84278-4c1a-4baf-beae-f2d5ce74b3b1)
- [483 - 2019-10-25](https://www.keypedia.com/records/483/apitoria-pharma-private-limited/c0a8f710-466e-418e-9774-c7f4bef69156)
- [483 - 2024-09-27](https://www.keypedia.com/records/483/apitoria-pharma-private-limited/c88a9780-f209-45af-8216-dbd21e03a3ee)

## Related Officers

- [Investigator](https://www.keypedia.com/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)
- [Khalid M. Khan](https://www.keypedia.com/people/khalid-m-khan/fb4bde8b-b17c-4686-b5af-e602c8a46e18)

Company: https://www.keypedia.com/companies/apitoria-pharma-private-limited/3fa64839-667a-4ce5-930b-a1935f0c2b38

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c