# FDA 483 - APL HEALTHCARE LIMITED - December 17, 2025

Source: https://www.keypedia.com/records/483/apl-healthcare-limited/e1147192-1806-402c-b649-2167c29018fd

> FDA 483 for APL HEALTHCARE LIMITED on December 17, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: APL HEALTHCARE LIMITED
- Inspection Date: 2025-12-17
- Product Type: Drugs
- Office Name: Baltimore District Office
- Summary: The FDA conducted an inspection of APL Healthcare Limited, a finished dosage drug manufacturer located in Menakuru, Andhra Pradesh, India, from December 8 to December 17, 2025. The inspection revealed several critical compliance issues. Key observations included deficiencies in complaint records, specifically the lack of comprehensive investigation findings and follow-up actions for leaking complaints related to batches manufactured in April and May 2023. Additionally, there was a failure to conduct shipping studies to assess the impact of varying air pressures and durations on product integrity.

Another significant issue was the inadequate change control process, particularly concerning the inclusion of an alternate container without proper verification or effectiveness checks. This oversight potentially led to an increase in leaking bottles. Moreover, a complaint regarding black specks in a liquid solution revealed insufficient investigation into potential contamination sources, such as the state of the filling machine.

The inspection also highlighted the absence of written and fully implemented responsibilities and procedures for the quality control unit. Furthermore, the firm's Quality Risk Management (QRM) assessments were found lacking in evaluating critical risks associated with high-potency products.

The FDA requires APL Healthcare Limited to address these violations by enhancing their complaint handling processes, conducting thorough investigations, implementing effective change controls, and improving their QRM assessments. Failure to comply may result in regulatory actions to ensure product safety and quality.

## Related Documents

- [483 - 2023-09-19](https://www.keypedia.com/records/483/apl-healthcare-limited/c059bd76-9885-41cc-a930-da938a5760b7)
- [483 - 2025-12-17](https://www.keypedia.com/records/483/apl-healthcare-limited/72e068b7-d003-4a5b-a37b-4f1dfb8d7eff)

## Related Officers

- [Investigator](https://www.keypedia.com/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)
- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.keypedia.com/companies/apl-healthcare-limited/d13ff022-135e-4790-b958-7f0667d985ab

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa