Company
United StatesTrigen Laboratories, Alpharetta, GA – FDA Inspections
Inspection records and compliance data for Trigen Laboratories in Alpharetta, Georgia. 5 FDA inspections on record (1 OAI), last inspected February 11, 2020.
Company Profile
This profile covers Trigen Laboratories based in Alpharetta, Georgia, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 3
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 24, 2010. Last inspected February 11, 2020.
Most cited issue areas
- Hold - temperature, humidity, light1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 11, 2020 | NAI | Foods & Cosmetics · Foodborne Biological Hazards | 1120589 |
| November 15, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1110707 |
| January 29, 2014 | VAI | Foods & Cosmetics, Human Drugs · Drug Quality Assurance | 864100 |
| December 20, 2010 | VAI | Human Drugs · Drug Quality Assurance | 702378 |
| February 24, 2010 | OAI | Human Drugs · Drug Quality Assurance | 646361 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Trigen Laboratories
FEI Number
3009428989
Address
1880 Mcfarland Pkwy Ste 110, Alpharetta, Georgia 30005, United States
Country
United States
ID: 95cc9286-e0e2-418c-90e3-f01944b0fbe3