# FDA EIR - Smilax Laboratories Limited - September 15, 2023

Source: https://www.keypedia.com/records/eir/smilax-laboratories-limited/72853482-d0e8-4037-857c-19fbdb39fb98

> FDA EIR for Smilax Laboratories Limited on September 15, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Smilax Laboratories Limited
- Inspection Date: 2023-09-15
- Product Type: drugs
- Summary: An FDA surveillance inspection of Smilax Laboratories Limited, a foreign non-sterile Active Pharmaceutical Ingredient (API) manufacturer in Vishakapatnam District, India, occurred from September 11 to September 15, 2023. This inaugural inspection, guided by regulatory frameworks including CP: #7356.002F and ICH Q7A for cGMP, assessed the company's Quality, Production, Laboratory Control, Material, and Facilities and Equipment systems. The primary violation identified was a deficiency in the firm's Quality system. Specifically, the company failed to adhere to its Standard Operating Procedure (SOP No. CQA008/03) for investigation and corrective and preventive action management, which required extending investigations to other potentially affected batches and products. This observation resulted in an FDA-483, Inspectional Observations, being issued. Smilax Laboratories Limited's Managing Director committed to implementing corrective actions and is required to submit a detailed written response within fifteen USA business days for FDA evaluation. The inspection's conclusion for this issue was classified as "Voluntary Action Indicated."

## Related Documents

- [483 - 2023-09-11](https://www.keypedia.com/records/483/smilax-laboratories-limited/2f1966eb-d6d5-4b0d-80d7-c38f349fecae)
- [483 - 2023-09-15](https://www.keypedia.com/records/483/smilax-laboratories-limited/fd59b2c7-48fb-4645-9567-7dc05e98fabc)

## Related Officers

- [recipient](https://www.keypedia.com/people/s-murali-krishna/9f761cbb-e240-4a8a-aee7-f7084fd666d0)
- [investigator](https://www.keypedia.com/people/luis-a-carrion/844cdfeb-654d-4d27-bbcd-712b9036fd00)
- [Hala L. Selby](https://www.keypedia.com/people/hala-l-selby/4b507d3e-3d23-4c0c-97d4-495a25dc3947)

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