Company
United StatesSouthwest Health Corp., San German, PR – FDA Inspections
Inspection records and compliance data for Southwest Health Corp. in San German, Puerto Rico. 6 FDA inspections on record, last inspected May 19, 2017.
Company Profile
This profile covers Southwest Health Corp. based in San German, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected February 26, 2009. Last inspected May 19, 2017.
Most cited issue areas
- Calibration/Inspection/Checking not done1 inspection
- Establish, maintain and follow manufacturing SOPs1 inspection
- Person performing, test results, interpretation1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 19, 2017 | NAI | Biologics · Blood and Blood Products | 1013479 |
| March 31, 2015 | NAI | Biologics · Blood and Blood Products | 919742 |
| March 18, 2013 | VAI | Biologics · Blood and Blood Products | 821394 |
| May 4, 2011 | NAI | Biologics · Blood and Blood Products | 723201 |
| October 29, 2009 | VAI | Biologics · Blood and Blood Products | 629666 |
| February 26, 2009 | NAI | Biologics · Blood and Blood Products | 566163 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Southwest Health Corp.
FEI Number
3004517274
Address
8 Calle Javilla, San German, Puerto Rico 00683, United States
Country
United States
ID: 54cd2a85-9137-448e-8219-eaaa0e4b7ed6