# Apitoria Pharma Private Limited – FDA 483, Aug 24, 2026

Source: https://www.keypedia.com/records/483/apitoria-pharma-private-limited/5dc40f04-873f-49b6-9fec-6492a723f917

> FDA 483 for Apitoria Pharma Private Limited on August 24, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apitoria Pharma Private Limited
- Inspection Date: 2026-08-24
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Apitoria Pharma Private Limited, an API manufacturer in Anakapalli District, India, was cited for significant quality unit deficiencies during an FDA inspection. Observations included inadequate investigations into numerous laboratory occurrences, a "repeat until pass" pattern for system suitability test failures without proper root cause analysis, and a failure to thoroughly investigate a leachable impurity and its impact on released API batches. These issues indicate a weak quality system risking unreliable product quality data.

## Related Documents

- [483 - 2023-05-19](https://www.keypedia.com/records/483/apitoria-pharma-private-limited/38af609e-8879-4c0f-80c9-c894629e447d) — date: May 19, 2023

## Related Officers

- [Bryan L. Mcguckin](https://www.keypedia.com/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

Company: https://www.keypedia.com/companies/apitoria-pharma-private-limited/2159759f-d5e0-45cb-b80a-98f263b7f763

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3