# FDA 483 - STYRAX LIFE SCIENCES PRIVATE LIMITED - June 07, 2024

Source: https://www.keypedia.com/records/483/styrax-life-sciences-private-limited/d492609f-652b-4b71-9418-abe4d361d047

> FDA 483 for STYRAX LIFE SCIENCES PRIVATE LIMITED on June 07, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: STYRAX LIFE SCIENCES PRIVATE LIMITED
- Inspection Date: 2024-06-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: This FDA Form 483 was issued to Styrax Life Sciences Pvt. Ltd., an API Intermediate Manufacturer in Anakapalli, following an inspection from June 3-7, 2024. The inspection revealed significant deficiencies in laboratory controls, specifically the failure to validate analytical methods for raw materials, in-process, and finished product testing. Additionally, the firm failed to perform identity testing on incoming raw materials used in manufacturing.

## Related Officers

- [Dogbeda F. Mackenzie](https://www.keypedia.com/people/dogbeda-f-mackenzie/c522e2cb-bf53-48f3-b88a-20b7aa0238d6)

Company: https://www.keypedia.com/companies/styrax-life-sciences-private-limited/3f1bc08f-256e-42b5-8b60-60671ebabb71

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