# FDA 483 - SriSai Biopharmaceutical Solutions LLC - February 23, 2023

Source: https://www.keypedia.com/records/483/srisai-biopharmaceutical-solutions-llc/1e02843e-f525-4e0b-8db6-fdd97a4bc90e

> FDA 483 for SriSai Biopharmaceutical Solutions LLC on February 23, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SriSai Biopharmaceutical Solutions LLC
- Inspection Date: 2023-02-23
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: This FDA Form 483 report details observations made at SriSai Biopharmaceutical Solutions LLC in Frederick, MD, a drug distributor/warehouse. The inspection revealed significant deficiencies in component control, drug product storage conditions, supplier qualification, and equipment calibration. These issues indicate a lack of robust quality systems necessary to ensure the identity, strength, quality, and purity of drug products.

## Related Officers

- [Investigator](https://www.keypedia.com/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)
- [Investigator](https://www.keypedia.com/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)

Company: https://www.keypedia.com/companies/srisai-biopharmaceutical-solutions-llc/405b4534-a3e0-4233-8fad-9b18efa713b1

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64