Drugs

CGMP Violations at China’s Shandong Vianor

A 5/8-5/10 FDA inspection at Shandong Vianor Biotech, Shandong, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 9/12 Warning Letter. Specific violations cited were:

failing to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards;
failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products; and
failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

FDA says the firm’s response was inadequate in that it lacked details of how it would address the observations and also did not include a retrospective review of the effects of CGMP deficiencies on the quality of its products already distributed in the U.S.

In addition, the letter says that during the inspection the firm initially barred the investigator from accessing a room identified as a laboratory. The investigator eventually was allowed to inspect the laboratory but found no equipment, it says. The company then stated that the laboratory was offsite at an undisclosed residence and that the investigator could not have access as it was not a convenient time, according to FDA.

The firm was placed on Import Alert 8/22. Shandong was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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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