Company
United StatesBiomedica Biological Testing Laboratories, San German, PR – FDA Inspections
Inspection records and compliance data for Biomedica Biological Testing Laboratories in San German, Puerto Rico. 2 FDA inspections on record, last inspected May 18, 2016.
Company Profile
This profile covers Biomedica Biological Testing Laboratories based in San German, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected January 24, 2014. Last inspected May 18, 2016.
Most cited issue areas
- Cleaning/maintenance records not kept1 inspection
- Deviations from laboratory control requirements1 inspection
- Following/documenting laboratory controls1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 18, 2016 | NAI | Human Drugs · Drug Quality Assurance | 970175 |
| January 24, 2014 | VAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 863534 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Biomedica Biological Testing Laboratories
FEI Number
1000131863
Address
160 Ave Interamericana Suite 201 (Secon, San German, Puerto Rico 00683, United States
Country
United States
ID: b0a795f2-4322-48b2-bf1b-9e0603437022