# FDA 483 - R.L. Fine Chem Private Limited - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/rl-fine-chem-private-limited/41f61c8d-1179-4561-86f2-333496a21942

> FDA 483 for R.L. Fine Chem Private Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: R.L. Fine Chem Private Limited
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: An FDA inspection of RL Fine Chem Pvt. Ltd. in Bangalore, India, a non-sterile API manufacturer, revealed significant deficiencies across multiple areas. Observations included inadequate facility design and maintenance leading to potential contamination, improper storage conditions for materials and finished goods, and failures in investigation procedures for batch deviations and complaints. Additionally, the firm's quality control unit did not fully adhere to its own training and CAPA procedures.

## Related Officers

- [Performance Improvement Coordinator](https://www.globalkeysolutions.net/people/tenzin-jangchup/733eb315-0eeb-40ce-af6d-03b406a9235d)

Company: https://www.globalkeysolutions.net/companies/rl-fine-chem-private-limited/9e030edf-1694-4488-bea6-8b6cab7b9efd

Office: https://www.globalkeysolutions.net/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0