Drugs

CGMP Violations at BBC Group

A 3/22-3/26 FDA inspection at BBC Group, Pumei Town, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/4 Warning Letter says specific violations were:

failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records or other records;
failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
failing to clean, maintain, and, at appropriate intervals 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.

The letter also cited unapproved new drug and misbranding violations involving a scented hand sanitizer product. BBC was placed on an FDA import alert on 9/30/20 because the information the company provided in response to an FDA request for records did not appear to conform to CGMP.

The agency recommended that the company retain a qualified consultant to perform a comprehensive audit of its entire operation for CGMP compliance and then assist it in meeting CGMP requirements.

BBC was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the actions.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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