# FDA 483 - Syntenza Pharmaceuticals, LLC - March 12, 2020

Source: https://www.keypedia.com/records/483/syntenza-pharmaceuticals-llc/fd964e6f-1c5b-46c9-9fa3-595641e4053b

> FDA 483 for Syntenza Pharmaceuticals, LLC on March 12, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Syntenza Pharmaceuticals, LLC
- Inspection Date: 2020-03-12
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Syntenza Pharmaceuticals, LLC in Edina, MN, revealed a significant deficiency in their postmarketing adverse drug experience reporting system. The firm lacked written procedures for surveillance, receipt, evaluation, and reporting of adverse drug experiences. Furthermore, the firm demonstrated a lack of awareness and involvement with procedures prepared and activities conducted by a contractor under the firm's name, indicating a critical breakdown in oversight.

## Related Officers

- [Investigator](https://www.keypedia.com/people/sharon-l-matson/1d2e6d91-1d00-455d-a2e6-a73b1c6b82cc)

Company: https://www.keypedia.com/companies/syntenza-pharmaceuticals-llc/32e1b448-ef53-4dcd-bfa2-9b9faf97771f

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d