Company
United StatesMennonite General Hospital, Inc., Aibonito, PR – FDA Inspections
Inspection records and compliance data for Mennonite General Hospital, Inc. in Aibonito, Puerto Rico. 8 FDA inspections on record, last inspected September 23, 2025.
Company Profile
This profile covers Mennonite General Hospital, Inc. based in Aibonito, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 1
- NAI
- 6
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected July 29, 2010. Last inspected September 23, 2025.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs1 inspection
- Legibility and indelibility1 inspection
- Person performing, test results, interpretation1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 23, 2025 | Not classified | Biologics | 1291586 |
| May 30, 2023 | NAI | Biologics · Blood and Blood Products | 1210198 |
| November 19, 2019 | NAI | Biologics · Blood and Blood Products | 1114056 |
| June 1, 2018 | NAI | Biologics · Blood and Blood Products | 1055332 |
| January 19, 2016 | NAI | Biologics · Blood and Blood Products | 967723 |
| March 19, 2014 | NAI | Biologics · Blood and Blood Products | 871472 |
| March 26, 2012 | VAI | Biologics · Blood and Blood Products | 774638 |
| July 29, 2010 | NAI | Biologics · Blood and Blood Products | 674578 |
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
Mennonite General Hospital, Inc.
FEI Number
2675246
Address
Jose C. Vazquez Street, Aibonito, Puerto Rico 00705, United States
Country
United States
ID: 320d0772-15f2-4e3f-9622-2ec54faef34c