Allergy Laboratories, Inc. - June 19, 2009
Issue Date
Jun 19, 2009
Region
Southwest
Category
Drug
$117.00
Address 1
1005 S.W. Second St.
City
Oklahoma City
State
OK
Zip/Postal Code
73109
Country
US
Inspection Range
Jun 16, 2009 - Jun 19, 2009
Pages
2
First Observation
There is no documentation of approval from CBER for the reprocessing of un-standardized Eastern Cottonwood Allergenic Extract Lot #019031708, the technician noticed that the Laminar Flow Hood had been inadvertently turned off. QA instructed manufacturing to recap all previously filled final container vials and pour the contents in the bulk container. The extract that was malls in volume was again subjected to repeat sterilization, defiled into final containers, passed release tests and was released for distribution.
Investigator(s): Omotunde O. Osunsanmi and Tracy J. Washington