enforcement

Repeat Fenwal International CGMP Issues Cited

A 1/27-2/5 FDA inspection at the Fenwal International facility in Maricao, PR, documented evidence of significant deviations from current good manufacturing practice (CGMP) requirements applicable to the firm’s manufacture of blood pack units and component solutions intended for the collection and storage of whole blood and blood components that the firm distributes in interstate commerce. A just-released 7/7 Notice of Violation says the specific violations were:

failure 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; and
failure to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair.

FDA says the company’s responses to the inspection observations were inadequate. It notes that FDA cited deficiencies in a 9/14/2023 Warning Letter, a 12/15/2023 regulatory meeting, and meetings following a 9/18/2024 inspection. “Your corrective actions appear limited in scope to only what is pointed out during our inspections as noted by subsequent inspections that identify additional examples of deteriorated conditions,” the letter says…. “You have not demonstrated that you are able to maintain your facilities and equipment in a state of repair that is suitable for the products you manufacture.”

Fenwal was told to submit a comprehensive plan to address the state of its facilities and equipment as a whole. It was told to respond with a list of specific actions it has taken or will take to address the violations and prevent their recurrence, with documentation showing that the matters have been addressed and 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