Drugs

Immunomedics FDA-483 Released

FDA has released the FDA-483 with 10 observations from a 3/2-3/10 inspection at Immunomedics, Inc., a Morris Plains, NJ, drug substance intermediate manufacturer. The observations were:

failing to establish procedures and controls designed to prevent microbiological contamination of the drug substance intermediate and related components;
failing to have in writing and fully follow responsibilities and procedures applicable to the quality control unit;
standard operating procedures are inadequate or not followed;
failing to exercise appropriate controls over computers or related laboratory and production systems;
the redacted process for bioreactors is a semi-automated process with enhanced control and monitoring of the process performed by protocol;
failing to adequately maintain and inspect facilities and equipment;
procedural controls are inadequate to assure the validated state is maintained;
analytical method verification studies were not performed for specified procedures during the lot release and stability testing of a redacted item at Immunomedics;
failing to complete qualification of equipment and to establish procedural controls for use; and
the redacted automated cell thawing equipment in the redacted area are not properly qualified to comply with their intended purpose.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome