FDA Inspection
Trigen LaboratoriesTrigen Laboratories – FDA Inspection, Nov 15, 2019
Record Details
This FDA Inspection record concerns Trigen Laboratories, with an inspection on November 15, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Trigen Laboratories
- Inspection Date
- November 15, 2019
- Product Type
- Devices
View Company Profile
ID · f3a8f1b5-f950-40a0-b140-ac00b6ba7a72
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1110707
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Trigen Laboratories
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 11, 2020 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| January 29, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 20, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 24, 2010 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Trigen Laboratories
- FDA Inspection 1120589 - 2020-02-11
- FDA Inspection 864100 - 2014-01-29
- FDA Inspection 702378 - 2010-12-20
- FDA Inspection 646361 - 2010-02-24
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.