# FDA 483 - Steriscience Specialties Private Limited - February 14, 2019

Source: https://www.globalkeysolutions.net/records/483/steriscience-specialties-private-limited/8abbc69f-97aa-4f0f-a22d-68df1a7635ab

> FDA 483 for Steriscience Specialties Private Limited on February 14, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Steriscience Specialties Private Limited
- Inspection Date: 2019-02-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Mylan Laboratories Limited in Bangalore, India, identified a significant issue with equipment design. Particulate matter was found in retention samples of drug products, linked to a component used in the filling process. The firm failed to conduct an in-use study to demonstrate that this component does not introduce unacceptable levels of particulates into the product.

## Related Documents

- [483 - 2013-08-19](https://www.globalkeysolutions.net/records/483/steriscience-specialties-private-limited/55cf68ce-65d3-4c02-81ae-e0f948e32ce6)
- [483 - 2015-09-01](https://www.globalkeysolutions.net/records/483/steriscience-specialties-private-limited/c8fff591-e664-4a7e-a4df-98d9625de10a)

## Related Officers

- [Director, Enterprise Regulatory Compliance](https://www.globalkeysolutions.net/people/nicholas-a-violand/c0c3ee7a-8adb-43d2-974c-06220ef8e8eb)
- [Bijoy Panicker](https://www.globalkeysolutions.net/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

Company: https://www.globalkeysolutions.net/companies/steriscience-specialties-private-limited/975a3188-8291-4516-ab80-57e5e3fed081

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