Company
United StatesImplantes y Sistemas Medicos Inc., Guaynabo, PR – FDA Inspections
Inspection records and compliance data for Implantes y Sistemas Medicos Inc. in Guaynabo, Puerto Rico. 3 FDA inspections on record, last inspected March 08, 2017.
Company Profile
This profile covers Implantes y Sistemas Medicos Inc. based in Guaynabo, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected May 30, 2012. Last inspected March 8, 2017.
Most cited issue areas
- Storage temperatures recorded, maintained2 inspections
- Shipping conditions appropriate1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 8, 2017 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1003667 |
| May 13, 2015 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 925641 |
| May 30, 2012 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 784191 |
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
Implantes y Sistemas Medicos Inc.
FEI Number
3005030856
Address
Calle Diana #22 Esquina Calle Emma, Amelia Industrial Park, Guaynabo, Puerto Rico 00969, United States
Country
United States
ID: 3b962b16-15c0-4603-a184-82e646472f91