# FDA 483 - Smilax Laboratories Limited - September 11, 2023

Source: https://www.globalkeysolutions.net/records/483/smilax-laboratories-limited/2f1966eb-d6d5-4b0d-80d7-c38f349fecae

> FDA 483 for Smilax Laboratories Limited on September 11, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Smilax Laboratories Limited
- Inspection Date: 2023-09-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Smilax Laboratories Limited in Parawada-Vishakapatnam, India, an Active Pharmaceutical Ingredient Manufacturer, revealed a significant issue with the firm's investigation and corrective and preventive action management. The firm failed to follow its own SOP, specifically by not extending investigations to other potentially affected batches and products following complaints of foreign particles and dead insects.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/luis-a-carrion/844cdfeb-654d-4d27-bbcd-712b9036fd00)

Company: https://www.globalkeysolutions.net/companies/smilax-laboratories-limited/289155c3-7a02-4142-95c8-e572daf2df84

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