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

Source: https://www.globalkeysolutions.net/records/483/apl-healthcare-limited/72e068b7-d003-4a5b-a37b-4f1dfb8d7eff

> 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: Office of Inspections and Investigations
- Summary: APL HEALTHCARE LIMITED in Menakuru, India, was cited for significant deficiencies across its quality system. Observations included inadequate complaint investigations for leaking products and particulate contamination, failure to follow quality control procedures, and deficient quality risk management for high-potency drugs. Additionally, the firm failed to establish accurate test methods, maintain clean equipment, and ensure proper cleaning validation before subsequent batch production.

## Related Documents

- [483 - 2023-09-19](https://www.globalkeysolutions.net/records/483/apl-healthcare-limited/c059bd76-9885-41cc-a930-da938a5760b7)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)
- [Investigator](https://www.globalkeysolutions.net/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)
- [Guerlin Ulysse](https://www.globalkeysolutions.net/people/guerlin-ulysse/2c5742f8-57bb-4269-b389-ec2e6358634d)

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

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8