Drugs

12 Observations in SterRx FDA-483

FDA has released a 26-page FDA-483 with 12 observations from a 9/21-11/4/21 inspection at SterRx, a Plattsburgh, NY, 503B outsourcing facility. The inspection observations were:

aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under pressure;
container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its cleaning and maintenance;
substances required for equipment operations such as lubricants and coolants come in contact with components and closures so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements;
failure 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;
procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment from contamination before use;
procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process;
protective apparel not worn as necessary to protect drug products from contamination;
the written stability program for drug products does not include meaningful test methods;
employees are not given training in the particular operations they perform as part of their function; and
complaint records are deficient in that they do not include the known reply to the complainant.

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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