# FDA 483 - Zydus Lifesciences Limited - August 10, 2018

Source: https://www.globalkeysolutions.net/records/483/zydus-lifesciences-limited/bd6c4685-d0aa-4c81-a7c5-e74ce3ba0a02

> FDA 483 for Zydus Lifesciences Limited on August 10, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zydus Lifesciences Limited
- Inspection Date: 2018-08-10
- Product Type: drugs
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: Watson Pharma Pvt. Ltd. in Ambernath Thane, India, a manufacturer, was cited with four observations during an FDA inspection. The observations highlight significant deficiencies in manufacturing process validation, control over critical raw material dispensing, completeness of material handling procedures, and adherence to laboratory controls and documentation practices. These issues indicate a lack of robust quality systems impacting product quality assurance.

## Related Officers

- [William Leonard](https://www.globalkeysolutions.net/people/william-leonard/1f11ece4-597c-4d3e-aac4-46f8ea404ec3)

Company: https://www.globalkeysolutions.net/companies/zydus-lifesciences-limited/882d7962-58d4-4de8-9d0b-86bf2cf4773e

Office: https://www.globalkeysolutions.net/offices/fda-district-office-silver-springs-maryland/079bb75c-3759-4baa-baed-4159edd64552