# FDA 483 - Stratus Pharmaceuticals Inc - December 08, 2014

Source: https://www.keypedia.com/records/483/stratus-pharmaceuticals-inc/5bebe53f-b768-48ae-834e-697391ee745c

> FDA 483 for Stratus Pharmaceuticals Inc on December 08, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stratus Pharmaceuticals Inc
- Inspection Date: 2014-12-08
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Stratus Pharmaceuticals Inc. in Miami, FL, was cited for significant deficiencies in its quality control unit, complaint handling procedures, and employee training during an FDA inspection. The firm failed to adequately investigate and report over a thousand product complaints, including those related to product quality and potential adverse events. These issues indicate a systemic breakdown in critical quality assurance processes and compliance with cGMP regulations.

## Related Documents

- [EIR - 2018-03-08](https://www.keypedia.com/records/eir/stratus-pharmaceuticals-inc/ac044100-74fb-4396-ab79-dfabd2c8d5e9)

## Related Officers

- [Richard A. Lyght](https://www.keypedia.com/people/richard-a-lyght/8d60b5c0-4acd-4abc-979a-fb4b3e82964d)
- [Ileana Barreto-Petit](https://www.keypedia.com/people/ileana-barreto-petit/e5c865ac-14a2-47d4-954b-464a865e8684)

Company: https://www.keypedia.com/companies/stratus-pharmaceuticals-inc/b5f2695d-33d9-4bde-aad6-87b1466e9dc7

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6