# FDA 483 - AXXELENT PHARMA SCIENCE PRIVATE LIMITED - June 21, 2024

Source: https://www.keypedia.com/records/483/axxelent-pharma-science-private-limited/5c3045f8-ba76-4a32-95c5-6d36633915eb

> FDA 483 for AXXELENT PHARMA SCIENCE PRIVATE LIMITED on June 21, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: AXXELENT PHARMA SCIENCE PRIVATE LIMITED
- Inspection Date: 2024-06-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Axxelent Pharma Science Private Limited in Sri City, India, was inspected by the FDA from June 17-21, 2024, and received a Form 483 with four observations. The inspection revealed significant deficiencies in quality control, including inadequate investigations into out-of-specification results, lack of proper equipment cleaning procedures, insufficient employee CGMP training, and poor laboratory record-keeping and data review practices. These issues indicate a systemic failure to adhere to current good manufacturing practices.

## Related Officers

- [Paranthaman Senthamarai Kannan](https://www.keypedia.com/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)

Company: https://www.keypedia.com/companies/axxelent-pharma-science-private-limited/0e17ded9-51c9-4db9-9ceb-e39cb2d439db

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