Drugs

13 Inspection Observations at Pharmedium Services

FDA has released the FDA-483 issued following a 11/27/17-12/22/17 inspection at Pharmedium Services, a Sugar Land, TX, drug outsourcing facility. The form lists these inspection observations:

the quality control unit lacks the responsibility and authority to reject all drug products;
the flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building is not designed to prevent contamination;
the firm failed to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
there is a failure to thoroughly investigate any unexplained discrepancy or failure of a batch, regardless of whether the batch has been distributed, or a failure to expand an investigation to assess other batches that may also be affected;
aseptic processing areas are deficient regarding systems for maintaining any equipment used to control aseptic conditions;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
procedures designed to prevent microbiological contamination of sterile drug products does not include adequate validation of aseptic processing;
· laboratory controls do not include establishment of scientifically sound and appropriate test procedures designed to assure that components, in-process materials, and drug products conform to appropriate standards of identity, strength, quality, and purity;
samples taken of drug products for determination of conformance to written specifications are not representative;
· input to and output from the computer, related systems of formulas, records, or data are not checked for accuracy;
drug product labeling does not contain information required by the law and regulations; and
the facility has not submitted a report to FDA identifying a product compounded during the 12/1/16-5/31/17 reporting period as required by law and regulations.

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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