# FDA 483 - Samanta Organics Pvt. Ltd. - January 17, 2025

Source: https://www.keypedia.com/records/483/samanta-organics-pvt-ltd/2e3d005a-949a-4079-80c2-581f4cc82c0a

> FDA 483 for Samanta Organics Pvt. Ltd. on January 17, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Samanta Organics Pvt. Ltd.
- Inspection Date: 2025-01-17
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Samanta Organics Pvt. Ltd., an API manufacturer in Boisar, Maharashtra, was cited for significant data integrity and quality system deficiencies during an FDA inspection. Observations included a QA manager altering and backdating incident reports, inadequate electronic data security, and an insufficient environmental monitoring program lacking acceptance criteria for critical areas. These issues indicate a serious breakdown in quality control and data management practices.

## Related Officers

- [Bryan L. Mcguckin](https://www.keypedia.com/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

Company: https://www.keypedia.com/companies/samanta-organics-pvt-ltd/ea5be26c-cf1a-45ec-ae2a-e4e9c913a144

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8