Company
United StatesRMC Orthopedic & Surgical, Inc., Guaynabo, PR – FDA Inspections
Inspection records and compliance data for RMC Orthopedic & Surgical, Inc. in Guaynabo, Puerto Rico. 5 FDA inspections on record, last inspected August 26, 2024.
Company Profile
This profile covers RMC Orthopedic & Surgical, Inc. based in Guaynabo, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected December 31, 2012. Last inspected August 26, 2024.
Most cited issue areas
- Storage temperatures recorded, maintained1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 26, 2024 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1248952 |
| November 20, 2019 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1114132 |
| December 28, 2017 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1037951 |
| October 29, 2015 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 947320 |
| December 31, 2012 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 813486 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
RMC Orthopedic & Surgical, Inc.
FEI Number
3008833256
Address
Corporate Office Park #42, Agm Building, Suite 102, Guaynabo, Puerto Rico 00966, United States
Country
United States
ID: 9b43711c-4a89-4f5e-bac0-402b17b2548e