Amphastar Nanjing Pharmaceuticals, Inc. - Oct. 11, 2019
Issue Date
Oct 11, 2019
Region
HQ
Category
Drug
$117.00
Contact Name
Henry Zhang
Contact Title
General Manager
Address 1
No. 5 Xinghe Rd.
City
Nanjing
State
Jiangsu
Zip/Postal Code
210038
Country
China
Inspection Range
Oct 07, 2019 - Oct 11, 2019
Pages
1
First Observation
Your Standard Operating Procedure ... and your Annual Product Reviews, including but not limited those for 2017 and 2018 ... show that your annual visual inspection of
retention samples includes inspection of the packaging and labeling, location of the samples and quantity. There is no inspection of the product itself.
Investigator(s): Angela E. Glenn