# FDA 483 - Sun Pharmaceutical Industries Ltd. - December 13, 2019

Source: https://www.keypedia.com/records/483/sun-pharmaceutical-industries-ltd/c01135a1-845e-424e-bc17-8ea96df798c1

> FDA 483 for Sun Pharmaceutical Industries Ltd. on December 13, 2019. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sun Pharmaceutical Industries Ltd.
- Inspection Date: 2019-12-13
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 documents observations from an inspection of Sun Pharmaceutical Industries Ltd., a sterile and non-sterile drug manufacturer in Halol, Gujarat, India, conducted from December 3-13, 2019. The inspection identified eight observations.

**Observation 1:** Lacked written procedures for production and process controls to ensure drug product identity, strength, quality, and purity. Specifically, the Quality Unit failed to implement adequate controls for (b)(4) injection, with multiple out-of-specification (OOS) and out-of-trend (OOT) results for content, and investigations failing to identify root causes.

**Observation 2:** Responsibilities and procedures for the quality control unit were not fully followed, particularly regarding data integrity in the MODA EM PROD version 3.4 computerized system for environmental monitoring. The system lacked controls to prevent data manipulation, and audit trails from 2016-2019 were not reviewed or trended. User roles had excessive access privileges, including editing and un-approving samples and test results without prior management authorization. Trend reports failed to include sample edits and edited test results. Additionally, a control procedure allowed release of batches with out-of-limit (OOL) cycle times based on finished product results, and raw material dispensing labels were found to be pre-typed and not contemporaneously completed, with the documented dispenser being the verifier, not the dispenser.

**

## Related Documents

- [483 - 2025-06-13](https://www.keypedia.com/records/483/sun-pharmaceutical-industries-ltd/78be3f43-0bce-40cf-9d32-6f8000c36331)
- [483 - 2018-02-23](https://www.keypedia.com/records/483/sun-pharmaceutical-industries-ltd/900452c3-8d0b-4801-bfb0-6232d5da6e83)
- [483 - 2018-08-31](https://www.keypedia.com/records/483/sun-pharmaceutical-industries-ltd/abb59bb7-597b-42c5-9ae3-f69941eb7b87)
- [483 - 2016-12-01](https://www.keypedia.com/records/483/sun-pharmaceutical-industries-ltd/a89c4d8f-1a9f-4c71-9ade-8cd450a0643b)
- [483 - 2019-06-11](https://www.keypedia.com/records/483/sun-pharmaceutical-industries-ltd/46808012-a2fb-45f6-8b29-9e553207cad7)

## Related Officers

- [Investigator](https://www.keypedia.com/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)
- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Dongping Dai](https://www.keypedia.com/people/dongping-dai/e3cd81c1-e1e8-4336-be62-45311c9d937b)

Company: https://www.keypedia.com/companies/sun-pharmaceutical-industries-ltd/0ee9565e-1ff7-4ffa-b6ad-c38bccdc32e6

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c