Drugs

Brands International Limits, Delays Inspection: FDA

FDA says that when it inspected the Brands International drug manufacturing facility in Newmarket, Ontario, Canada, company officials there limited and delayed the inspection in several ways. A 12/17 Warning Letter says the investigators also identified these current good manufacturing practice (CGMP) regulation violations:

failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
failure to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release;
failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failure to validate and establish the reliability of the firm’s component supplier’s test analyses at appropriate intervals;
failure to have buildings used in the manufacture, processing, packing, or holding of drug products with adequate space for the orderly placement of equipment and materials to prevent mixups and contamination; and
failure of the firm’s quality control unit to exercise its responsibility to ensure manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

FDA recommends that the company engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. It acknowledges the firm’s actions in recalling some of its products due to CGMP violations and the potential presence of mold.

Products offered for import into the U.S. were placed on a 10/28/2024 Import Alert.

Brands International was told to respond with a list of specific actions it has taken to address any violations and prevent their recurrence, with a schedule for completing the corrections.

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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