Company
United StatesStratus Pharmaceuticals Inc, Miami, FL – FDA Inspections
Inspection records and compliance data for Stratus Pharmaceuticals Inc in Miami, Florida. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected August 15, 2024.
Company Profile
This profile covers Stratus Pharmaceuticals Inc based in Miami, Florida, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 0
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 8, 2014. Last inspected August 15, 2024.
Most cited issue areas
- Procedures not in writing, fully followed2 inspections
- Adverse Drug Experience1 inspection
- Complaints reviewed by Quality Control Unit1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 15, 2024 | Not classified | Human Drugs · Drug Quality Assurance | 1247052 |
| April 21, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1168476 |
| March 8, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1050585 |
| December 8, 2014 | OAI | Human Drugs · Unapproved and Misbranded Drugs | 906972 |
FDA documents
Form 483s (1)
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Company Information
Name
Stratus Pharmaceuticals Inc
FEI Number
3002787468
Address
12379 SW 130th St, Miami, Florida 33186, United States
Country
United States
ID: b5f2695d-33d9-4bde-aad6-87b1466e9dc7