Hi-Tech Pharmacal - July 15, 2016
Issue Date
Jul 15, 2016
Region
Northeast
Category
Drug
$117.00
Contact Name
Eyal Mares
Contact Title
Vice President and General Manager, Amityville Operation
Address 1
369 Bayview Ave.
City
Amityville
State
NY
Zip/Postal Code
11701-2801
Country
United States
Inspection Range
Jul 06, 2016 - Jul 15, 2016
Pages
1
First Observation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
Investigator(s): Marie B. Buen-Bigornia, Mindy M. Chou, Sony Mathews, Helen B. Ricalde, Robert C. Steyert, and Alice S. Tsao