# FDA 483 - Steriscience Specialties Private Limited - December 20, 2019

Source: https://www.keypedia.com/records/483/steriscience-specialties-private-limited/bcecdef1-061a-4a6b-ab8f-3c0ec574ee0a

> FDA 483 for Steriscience Specialties Private Limited on December 20, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steriscience Specialties Private Limited
- Inspection Date: 2019-12-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Mylan Laboratories Limited (Sterile Products Division) in Bangalore, India, received a Form 483 for failing to thoroughly review unexplained discrepancies. The firm's investigation into product discoloration and improper vial stoppers, which led to product recalls, was not adequately extended to other sterile and liquid drug products manufactured using the same detection system. This indicates a significant deficiency in their quality system for discrepancy management and product control.

## Related Documents

- [483 - 2024-03-28](https://www.keypedia.com/records/483/steriscience-specialties-private-limited/9d9699c8-ab22-4b99-8d85-be893a5e8a4a)

## Related Officers

- [Jose F. Velez](https://www.keypedia.com/people/jose-f-velez/0d1951e8-3aa5-48ff-bc54-1fae8a7a57c9)

Company: https://www.keypedia.com/companies/steriscience-specialties-private-limited/f2814c8b-daff-42a4-abe2-59947a5bda3d

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