# FDA 483 - APL HEALTHCARE LIMITED - September 19, 2023

Source: https://www.keypedia.com/records/483/apl-healthcare-limited/c059bd76-9885-41cc-a930-da938a5760b7

> FDA 483 for APL HEALTHCARE LIMITED on September 19, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: APL HEALTHCARE LIMITED
- Inspection Date: 2023-09-19
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: APL HEALTHCARE LIMITED, a finished dosage drug manufacturer in Nellore, India, was cited for significant failures in its quality control system during an FDA inspection from September 13-19, 2023. The firm failed to thoroughly review discrepancies and ensure scientifically justified conclusions for non-conformance investigations. This included issues with widening specifications without justification, inadequate production record-keeping, and a lack of investigations into recurring laboratory non-conformances.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd