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Malladi Drugs & Pharmaceuticals Pvt Ltd. - Oct. 9, 2018
Issue Date
Oct 09, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
PPS Kishore
Contact Title
Vice President, Manufacturing
Address 1
49-50 Plots & 55 Ida
Address 2
Gajulamandyarin
City
Andra Pradesh
Zip/Postal Code
517520
Country
India
Inspection Range
Oct 01, 2018 - Oct 09, 2018
Pages
8
First Observation
Batch production and laboratory control records of critical process steps are not reviewed and approved by the quality unit(s) before an intermediate or API batch is released or distributed.
Investigator(s): Kellia N. Hicks