Company
United StatesDowning Labs, LLC, Dallas, TX – FDA Inspections
Inspection records and compliance data for Downing Labs, LLC in Dallas, Texas. 7 FDA inspections on record (6 OAI), 1 Form 483, last inspected November 19, 2018.
Company Profile
This profile covers Downing Labs, LLC based in Dallas, Texas, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 6
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected April 16, 2013. Last inspected November 19, 2018.
Most cited issue areas
- Absence of Written Procedures3 inspections
- Cleaning System3 inspections
- Environmental Monitoring System3 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 19, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1072541 |
| October 28, 2016 | OAI | Human Drugs · Drug Quality Assurance | 990200 |
| April 22, 2016 | OAI | Human Drugs · Drug Quality Assurance | 967044 |
| March 3, 2016 | OAI | Human Drugs · Drug Quality Assurance | 960843 |
| October 9, 2015 | OAI | Human Drugs · Drug Quality Assurance | 945306 |
| July 16, 2014 | OAI | Human Drugs · Drug Quality Assurance | 887817 |
| April 16, 2013 | OAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 825163 |
FDA documents
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Downing Labs, LLC
FEI Number
3010087152
Address
4001 Mcewen Rd Ste 110, Dallas, Texas 75244, United States
Country
United States
ID: 58d772b6-995b-45ec-82ba-17256caa081c