Company
United StatesProCore Pharma, LLC, Coppell, TX – FDA Inspections
Inspection records and compliance data for ProCore Pharma, LLC in Coppell, Texas. 3 FDA inspections on record (1 OAI), last inspected June 26, 2013.
Company Profile
This profile covers ProCore Pharma, LLC based in Coppell, Texas, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected May 4, 2009. Last inspected June 26, 2013.
Most cited issue areas
- Absence of Written Procedures2 inspections
- Lack of written stability program2 inspections
- Written procedures not established/followed2 inspections
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 26, 2013 | VAI | Animal Drugs & Feeds, Foods & Cosmetics, Human Drugs · Foodborne Biological Hazards | 844207 |
| September 8, 2011 | OAI | Animal Drugs & Feeds, Foods & Cosmetics, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 742077 |
| May 4, 2009 | VAI | Foods & Cosmetics, Human Drugs · Colors and Cosmetics Technology | 582249 |
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
ProCore Pharma, LLC
FEI Number
3010165198
Address
1025 S Belt Line Rd Ste 100, Coppell, Texas 75019, United States
Country
United States
ID: e3e8d66c-0774-4480-ae06-6cfc2d7f7ec0