# FDA 483 - Medispray Laboratories Private Limited - January 20, 2025

Source: https://www.keypedia.com/records/483/medispray-laboratories-private-limited/c966544f-65db-41c4-adaa-0a943759ede9

> FDA 483 for Medispray Laboratories Private Limited on January 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medispray Laboratories Private Limited
- Inspection Date: 2025-01-20
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Medispray Laboratories Private Limited, a finished drug product manufacturer in Ponda, Goa, India, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's quality control unit, including a lack of written procedures and adherence to them. Specifically, issues were noted with in-process quality control testing data integrity, inadequate investigation of measurement failures, and shared login credentials for critical software.

## Related Documents

- [483 - 2025-01-20](https://www.keypedia.com/records/483/medispray-laboratories-private-limited/d44c0acf-cf01-41e5-bdae-1b2ad7fee5a6)

## Related Officers

- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.keypedia.com/companies/medispray-laboratories-private-limited/1633b4c0-6776-4222-af67-4cd6c51eba87

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