# FDA 483 - AIRIS PHARMA PRIVATE LIMITED - February 03, 2024

Source: https://www.globalkeysolutions.net/records/483/airis-pharma-private-limited/66ecbe88-de3d-4a60-a3a1-01ae7edc9897

> FDA 483 for AIRIS PHARMA PRIVATE LIMITED on February 03, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AIRIS PHARMA PRIVATE LIMITED
- Inspection Date: 2024-02-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: AIRIS PHARMA PRIVATE LIMITED, a contract testing laboratory in Hyderabad, India, was cited by the FDA for significant deficiencies within its quality control unit. The inspection revealed a lack of written procedures for reporting to the agency, oversight of contract organizations, and reviewer qualification. Additionally, documentation for a stability chamber requalification study was found to be incomplete.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/airis-pharma-private-limited/fcbdc54b-e886-4781-a723-bf4bcf9c537d

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