Downing Labs, LLC - Oct. 9, 2015
Issue Date
Oct 09, 2015
Region
Southwest
Category
Drug
$117.00
Contact Name
Ashley M. Downing
Contact Title
Co-owner
Address 1
4001 McEwen Rd.
Address 2
Ste. 110
City
Dallas
State
TX
Zip/Postal Code
75244-5020
Country
United States
Inspection Range
Sep 14, 2015 - Oct 09, 2015
Pages
14
First Observation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Investigator(s): Jenny A. Agila Sefen, Patrice Hall, and Jeffrey D. Meng