# FDA 483 - Jyoti Simple Solutions Private Limited - August 11, 2022

Source: https://www.keypedia.com/records/483/jyoti-simple-solutions-private-limited/ec1148ae-c213-4990-8f88-d7eab24b1036

> FDA 483 for Jyoti Simple Solutions Private Limited on August 11, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jyoti Simple Solutions Private Limited
- Inspection Date: 2022-08-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Jyoti Simple Solutions Private Limited, an intermediate manufacturer in Ahmedabad, Gujrat, received a Form FDA 483 with eight observations. The inspection revealed significant deficiencies across its quality system, including inadequate procedures, lack of material testing, insufficient employee training, and poor record-keeping. These issues indicate a broad failure to adhere to cGMP requirements for the production of pharmaceutical intermediates.

## Related Officers

- [Investigator](https://www.keypedia.com/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)

Company: https://www.keypedia.com/companies/jyoti-simple-solutions-private-limited/032e93b4-8fcb-4522-a97d-81e1a83d63b3

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