Drugs

Coastal Meds Inspection Observations

FDA has released the FDA-483 issued following a 3/12-4/6 inspection at Coastal Meds, a Nashville, TN, outsourcing facility. Specific observations listed on the form were:

aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
protective apparel is not worn as necessary to protect drug products from contamination;
aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions;
· laboratory controls do not include establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
procedures designed to prevent microbiological contamination of drug product purporting to be sterile do not include adequate validation of the sterilization process;
buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning;
there is a failure to thoroughly review 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;
each lot of drug product containers and closures is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit;
drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality, and purity at the time of use;
equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, strength, quality, or purity of the drug product; and
the 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