Pharmaceutical Manufacturing Research Services, Inc. - Jan. 20, 2015
Issue Date
Jan 20, 2015
Region
Central
Category
Drug
$117.00
Contact Name
Edwin R. Thompson
Contact Title
President
Address 1
202 Precision Rd.
City
Horsham
State
PA
Zip/Postal Code
19044-1227
Country
United States
Inspection Range
Jan 12, 2015 - Jan 20, 2015
Pages
2
First Observation
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release.
Investigator(s): Anita R. Michael