# FDA 483 - Sun Pharmaceutical Industries, Inc. - December 23, 2019

Source: https://www.keypedia.com/records/483/sun-pharmaceutical-industries-inc/71f35efa-bfd5-4df3-a2cc-2a2c5673cd35

> FDA 483 for Sun Pharmaceutical Industries, Inc. on December 23, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sun Pharmaceutical Industries, Inc.
- Inspection Date: 2019-12-23
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: PharmaLucence, Inc. in Billerica, MA, was inspected and received a Form 483 with four observations. The inspection revealed significant issues including inadequate investigations into out-of-specification results, failures in equipment qualification and requalification, lack of proper incoming raw material testing, and improper storage of reserve drug product samples. These findings indicate a moderate level of non-compliance with GMP regulations, particularly concerning quality control and equipment management.

## Related Documents

- [483 - 2025-04-18](https://www.keypedia.com/records/483/sun-pharmaceutical-industries-inc/6d67dfb6-ce41-4aa1-b4d4-11718b3709b1)

## Related Officers

- [Investigator](https://www.keypedia.com/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)
- [Robert J. Martin](https://www.keypedia.com/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)

Company: https://www.keypedia.com/companies/sun-pharmaceutical-industries-inc/1a56d6cb-288c-42d5-9558-e4301ffebc65

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94