483
Bristol-Myers Squibb CompanyBristol-Myers Squibb Company – FDA 483, Mar 19, 2010
Record Details
Celgene Corporation, a corporate headquarters and control testing laboratory in Summit, NJ, was cited for significant quality control and production procedure deficiencies. Observations included inadequate visual inspection criteria for Azacitidine for Injection, leading to potential contamination, and a systemic failure to timely investigate critical deviations. Additionally, the firm used unvalidated API in commercial products and did not complete annual product reviews on time.
View Company Profile
ID · b6214f1f-de9b-4681-8439-78f3587411b7
Other documents for Bristol-Myers Squibb Company
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.