Drugs

Aseptic Breakdowns at Sanofi’s Fill-Finish Plant: FDA

FDA has cited significant lapses in aseptic manufacturing practices at Sanofi’s sterile drug-product facility in Anagni, Italy, following a 5/2023 inspection that resulted in a just-posted Form 483 detailing multiple contamination risks. Inspectors visiting the site reported that procedures intended to prevent microbiological contamination were not consistently established or followed. The facility, which performs sterile fill-finish operations, was observed to have recurring problems with aseptic setup, equipment handling, and operator technique, according to the inspection form.

The agency said operators failed to perform aseptic setup of sterilized stopper bowl components, exposing parts to ISO 8 air before installation and then relying on post-setup cleaning and decontamination. Inspectors also documented non-sterile gloves being used to make aseptic connections and noted that operators frequently blocked “first air” over sterile components, it said.

In one instance, an operator touched an unprotected sterile tubing end with gloved hands during setup and again during installation. FDA said it also observed handling practices that compromised the sterility of equipment during both setup and manufacturing.

Inspectors flagged Sanofi’s practice of moving vials subject to rejection into the same equipment train as acceptable vials before performing line clearance. The agency reported that the firm did not provide a risk assessment addressing potential cross-contamination from this practice.

Another observation focused on the firm’s aseptic process simulations. FDA found that the equipment used for media fills did not match the equipment used in actual production, stating that the facility ran simulations on dedicated units rather than the fill-finish equipment used for commercial drug batches.

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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