Drugs

Maitland Labs FDA-483

FDA has released the FDA-483 issued following a 2/19-2/28 inspection at Maitland Labs of Central Florida, an Orlando, FL, 503B outsourcing facility. The seven inspection observations were:

aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions;
failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed;
failing to have a written testing program designed to assess drug product stability characteristics;
aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure;
failing to laboratory test each batch of drug product purporting to be sterile and pyrogen-free to determine conformance to such requirements;
labels of the outsourcing facility’s drug products are deficient; and
container labels of the outsourcing facility’s drug products are deficient.

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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