# FDA 483 - Biocon Generics Inc. - February 02, 2022

Source: https://www.keypedia.com/records/483/biocon-generics-inc/e6f00883-ba18-4768-9427-f7054e072b3a

> FDA 483 for Biocon Generics Inc. on February 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocon Generics Inc.
- Inspection Date: 2022-02-02
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: EYWA PHARMA INC, a pharmaceutical drug manufacturer in Cranbury, NJ, was cited for significant deficiencies during an FDA inspection from January 24 to February 2, 2022. Observations included inadequate investigations into out-of-specification results, failure to conduct risk assessments for process changes, and a lack of proper cleaning validation and procedures for manufacturing equipment. These issues indicate a systemic breakdown in quality control and adherence to good manufacturing practices.

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## Related Officers

- [Vivin George](https://www.keypedia.com/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)
- [Sony Mathews, CSO- Drug Specialist](https://www.keypedia.com/people/sony-mathews-cso-drug-specialist/968d63b0-4823-4009-8c2d-b19e95bfaaaa)

Company: https://www.keypedia.com/companies/biocon-generics-inc/6a3ff7cc-6109-49f1-a410-0ff09273673f

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248