# FDA 483 - R.S.A. Corp. - February 21, 2025

Source: https://www.keypedia.com/records/483/rsa-corp/2fc43a91-ee81-45e0-802b-dc521692fa3d

> FDA 483 for R.S.A. Corp. on February 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: R.S.A. Corp.
- Inspection Date: 2025-02-21
- Product Type: drugs
- Office Name: New England District Office
- Summary: R.S.A. Corp. in Danbury, CT, an API manufacturer, was cited for significant quality control deficiencies during an FDA inspection. Observations included failures in raw material testing, supplier qualification, deviation investigations, analytical method procedures, and equipment cleaning validation. These issues indicate a lack of robust controls over critical aspects of API manufacturing.

## Related Officers

- [National Expert, Pharmaceutical](https://www.keypedia.com/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)

Company: https://www.keypedia.com/companies/rsa-corp/d731050b-36e3-475d-9748-8defc5556e50

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144