APL Health Care Ltd. - Dec. 21, 2018
Issue Date
Dec 21, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Tapas Kumar Mahapatra
Contact Title
Vice President, Operations
Address 1
Plot No. S-1/B, TSIIC SEZ, Green Industrial Area
Address 2
Polepally Village
City
Mahabubnagar
State
Telangana
Zip/Postal Code
509302
Country
India
Inspection Range
Dec 17, 2018 - Dec 21, 2018
Pages
38
First Observation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Saleem A. Akhtar