Company
United StatesSaint Lukes Memorial Hospital, Inc., Ponce, PR – FDA Inspections
Inspection records and compliance data for Saint Lukes Memorial Hospital, Inc. in Ponce, Puerto Rico. 5 FDA inspections on record, last inspected July 24, 2017.
Company Profile
This profile covers Saint Lukes Memorial Hospital, Inc. based in Ponce, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected May 11, 2010. Last inspected July 24, 2017.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs2 inspections
- Authority lacking to review records, investigate errors1 inspection
- Thorough investigations1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 24, 2017 | NAI | Biologics · Blood and Blood Products | 1020841 |
| July 2, 2015 | NAI | Biologics · Blood and Blood Products | 933503 |
| February 14, 2014 | NAI | Biologics · Blood and Blood Products | 866263 |
| June 28, 2012 | VAI | Biologics · Blood and Blood Products | 788465 |
| May 11, 2010 | VAI | Biologics · Blood and Blood Products | 659338 |
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
Saint Lukes Memorial Hospital, Inc.
FEI Number
1000526693
Address
917 Ave Tito Castro, Ponce, Puerto Rico 00716, United States
Country
United States
ID: 5da5039f-a787-4566-9104-b924408e3160