# FDA 483 - R.L. Fine Chem Private Limited - April 14, 2023

Source: https://www.globalkeysolutions.net/records/483/rl-fine-chem-private-limited/f63746a4-6aaa-41b9-8247-7a14bfbfe95e

> FDA 483 for R.L. Fine Chem Private Limited on April 14, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: R.L. Fine Chem Private Limited
- Inspection Date: 2023-04-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: R.L. Fine Chem Private Limited, an API manufacturer in Chikkaballapur, India, was cited with two observations during an FDA inspection. The firm failed to adequately investigate critical deviations related to stability chamber excursions and did not analyze stability samples within established timeframes. These issues indicate deficiencies in quality control and adherence to established procedures.

## Related Officers

- [Vivin George](https://www.globalkeysolutions.net/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)

Company: https://www.globalkeysolutions.net/companies/rl-fine-chem-private-limited/0d4843a2-1d91-4843-9d85-2c15515478e6

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1