# FDA 483 - Rakshit Drugs Private Limited - November 22, 2024

Source: https://www.globalkeysolutions.net/records/483/rakshit-drugs-private-limited/00973d3f-5378-43ec-bda4-4258badebbce

> FDA 483 for Rakshit Drugs Private Limited on November 22, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rakshit Drugs Private Limited
- Inspection Date: 2024-11-22
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Rakshit Drugs Private Limited in Anakapalli, India, an API and intermediate manufacturer, revealed significant deficiencies in quality control. Observations included inadequate equipment cleaning procedures, insufficient equipment qualification, flawed out-of-specification investigations, and unsecured computerized system data backups. Additionally, improper microbiological water quality analysis was noted, indicating systemic issues in ensuring product quality and data integrity.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)

Company: https://www.globalkeysolutions.net/companies/rakshit-drugs-private-limited/fdf82bfd-e88c-46c5-806a-8f87d4f6e309

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