# FDA 483 - Swati Spentose Private Limited - May 31, 2024

Source: https://www.keypedia.com/records/483/swati-spentose-private-limited/afee216b-b606-4562-9450-cbf9b1a85d9b

> FDA 483 for Swati Spentose Private Limited on May 31, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Swati Spentose Private Limited
- Inspection Date: 2024-05-31
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Swati Spentose Private Limited, an API Non-Sterile Drug Substance Manufacturer in Vapi, India, was cited with two observations during an FDA inspection. The inspection revealed significant deficiencies in employee training, specifically for QC laboratory reviewers, and a systemic failure within the quality control unit to follow approved testing procedures, leading to a high number of recurring human errors.

## Related Officers

- [Ankur C. Patel](https://www.keypedia.com/people/ankur-c-patel/602c7d14-2c48-4929-a07b-6e4c235d7f13)

Company: https://www.keypedia.com/companies/swati-spentose-private-limited/829926c8-b657-4a0d-ae81-83501694ede3

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3