# FDA 483 - Steriscience Specialties Private Limited - March 28, 2024

Source: https://www.keypedia.com/records/483/steriscience-specialties-private-limited/9d9699c8-ab22-4b99-8d85-be893a5e8a4a

> FDA 483 for Steriscience Specialties Private Limited on March 28, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steriscience Specialties Private Limited
- Inspection Date: 2024-03-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Steriscience Specialties Private Limited in Bengaluru, India, revealed significant deficiencies in quality control, manufacturing processes, and record-keeping. The firm released drug products containing rejected API, conducted inadequate investigations into product discrepancies and environmental excursions, and failed to properly train visual inspectors. These issues indicate a systemic lack of adherence to established quality standards for sterile drug manufacturing.

## Related Documents

- [483 - 2019-12-20](https://www.keypedia.com/records/483/steriscience-specialties-private-limited/bcecdef1-061a-4a6b-ab8f-3c0ec574ee0a)

## Related Officers

- [Xiaokuang Lai](https://www.keypedia.com/people/xiaokuang-lai/6c25851d-0954-4f42-8f14-c2e0382e6815)
- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

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