Par Sterile Products, LLC - Aug. 9, 2018
Issue Date
Aug 09, 2018
Region
Central
Category
Drug
$117.00
Contact Name
Terrance J. Coughlin
Contact Title
Chief Operating Officer
Address 1
870 Parkdale Rd.
City
Rochester
State
MI
Zip/Postal Code
48307
Country
United States
Inspection Range
Jul 31, 2018 - Aug 09, 2018
Pages
8
First Observation
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Investigator(s): Mihaly S. Ligmond and Omotunde O. Osunsanmi