# FDA 483 - Astral SteriTech Private Ltd. - June 20, 2023

Source: https://www.keypedia.com/records/483/astral-steritech-private-ltd/192e0ddf-46c2-4cfd-91b1-e7bdbf2ddbd8

> FDA 483 for Astral SteriTech Private Ltd. on June 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Astral SteriTech Private Ltd.
- Inspection Date: 2023-06-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Astral SteriTech Private Ltd. in Vadodara, India, a sterile drug manufacturer, revealed four significant observations. The firm exhibited inadequate aseptic processing controls, including deficient cleaning and disinfection, and unreliable environmental monitoring data that led to a product recall. Further issues included poor facility maintenance in classified areas and a lack of validation for aseptic processes and sterilization, indicating severe breakdowns in quality control and manufacturing practices.

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Rodney G Raiford](https://www.keypedia.com/people/rodney-g-raiford/936d06fa-56be-4549-bfdf-992d616e2124)

Company: https://www.keypedia.com/companies/astral-steritech-private-ltd/89c2685a-6882-462d-880c-3c9396c5dd74

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