Company
United StatesBio Tech Med Corp., San German, PR – FDA Inspections
Inspection records and compliance data for Bio Tech Med Corp. in San German, Puerto Rico. 5 FDA inspections on record, last inspected January 31, 2020.
Company Profile
This profile covers Bio Tech Med Corp. based in San German, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected December 11, 2009. Last inspected January 31, 2020.
Most cited issue areas
- Procedures and release criteria1 inspection
- Review and approval-responsible person1 inspection
- Storage temperatures recorded, maintained1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 31, 2020 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1117665 |
| December 7, 2017 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1037952 |
| October 27, 2015 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 947311 |
| July 2, 2013 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 839741 |
| December 11, 2009 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 635042 |
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
Bio Tech Med Corp.
FEI Number
3007946244
Address
12th Street, A-28, Reparto Universidad, San German, Puerto Rico 00683, United States
Country
United States
ID: 25bca5db-dab5-477a-901d-7a716928b4b4