# FDA 483 - ZYDUS LIFESCIENCES LIMITED - August 05, 2022

Source: https://www.keypedia.com/records/483/zydus-lifesciences-limited/526e9778-49d9-4bc9-b141-4277fae2da3f

> FDA 483 for ZYDUS LIFESCIENCES LIMITED on August 05, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ZYDUS LIFESCIENCES LIMITED
- Inspection Date: 2022-08-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: ZYDUS LIFESCIENCES LIMITED, a finished drug manufacturer in Ahmedabad, India, received a Form 483 with four observations. The inspection revealed significant issues including repeated failures to thoroughly investigate out-of-specification results and implement corrective actions, as well as a lack of adequate written procedures for process controls, hold times, and sampling. These deficiencies indicate a systemic breakdown in quality assurance and process control for commercialized drug products.

## Related Documents

- [483 - 2019-05-03](https://www.keypedia.com/records/483/zydus-lifesciences-limited/051be815-7257-4aef-b52e-f6f008747283)

## Related Officers

- [Investigator](https://www.keypedia.com/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)
- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.keypedia.com/companies/zydus-lifesciences-limited/aa40e2a7-c250-4524-b05f-6ca311474c5c

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1