test page

Test Group 3

A Barbara Wilimczyk Marci break plastic down through chemical recycling Carcinogenic Potency Categorisation Change Management deficiency Chinese Pharma Manufacturer Chromatographic Sequence control Deficient Quality and Management oversight dissolution methods system suitability GxP Computer system deficiencies Test1

Test Group1

Aborter chromatograms Acceptable Intake Accord B C

Test Group 2

Aborter chromatograms Acceptable Intake Acceptable Intake (AI) Advisory Actions

New Test Tag Group

AI ALCOA

New Tag Group For Test

alosetron hydrochloride Alprazolam

FDA Auditors

Advisory Actions Andrew W Evensons Anesthesia M Shilds Arsen Karapetyan USFDA Investigator Eileen A. Liu Jose E Melendez Justin A Boyd Muna Algharibeh Pratik S Upadhyay Rajiv R Srivastava Rita K Kabaso Saleem A Akhtar Sandra Boyd Sayyem Akbar Wenzheng Zhang

Audit Citings, Areas

Aborted chromatogram Analyst error aseptic Aseptic operation deficiencies aseptic practices Aseptic simulation studies Audit trails Cleaning Cleaning Deficiency Complaints Compliance Contaminants Contamination cross contamination Data Integrity Deviations differential pressure differential pressures Document Control electronic data Electronic Data Control Extraneous peaks Glass particles glass particulates Guideline hold time studies Injectables invalidation of OOS Manufacturing investigation Method Transfer Microbial contamination OOS Investigations OOT Operator practices out of specifications Quality oversight Residue Cleaned Equipment Residues Residues in Clean equipment smoke studies Sterile process controls Temperature excurson

New Test

A

Recall Reasons

aseptic Aseptic operation deficiencies aseptic practices Bacillus Cereus Black particles blue plastic in tablet