Drugs

13 Observations in Zhejiang Hushai Inspection

FDA has released the form FDA-483 with 13 observations from a 4/13-4/24 inspection at the Zhejiang Hushai Pharmaceutical Co. drug manufacturing facility in Zhejiang, China. The inspection observations were:

failure to make written records of investigations into unexplained discrepancies or the failure of a batch or any of its components to meet specifications;
failure to establish and follow written procedures to prevent microbiological contamination of drug products purporting to be sterile, including adequate validation of the sterilization process;
aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions;
failure of laboratory records to include complete data derived from all tests, examinations, and assays necessary to assure compliance with established specifications and standards;
failure of laboratory controls to include the 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;
failure to establish control procedures which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process materials and the drug product;
In-process specifications for sampling and testing of in-process materials and drug products were not derived from previous acceptable process average and process variability estimates and were not determined by the application of suitable statistical procedures;
failure to maintain equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
failure of written records of investigation of a drug complaint to include the follow-up;
backup data is not assured as exact, complete, and secure from alteration, erasure, or loss through keeping hard copy or alternate systems;
failure to provide equipment for adequate control over air pressure, microorganisms, dust, humidity, and temperature when appropriate for the manufacture, processing, packing, or holding of a drug product; and
failure to fully follow the responsibilities and procedures applicable to the quality control unit.

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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