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Regulatory Focus™ > News Articles > 2019 > 3 > FDA Warns Pennsylvania Drugmaker Over GMP Violations

FDA Warns Pennsylvania Drugmaker Over GMP Violations

Posted 05 March 2019 | By Michael Mezher 

FDA Warns Pennsylvania Drugmaker Over GMP Violations

The US Food and Drug Administration (FDA) last month warned Vilvet Pharmaceuticals over good manufacturing practice (GMP) issues and for failing to list two of its products with the agency.
The warning letter comes after a 10-day inspection of Vilvet’s Chester Springs, PA facility in June 2018.
According to FDA, Vilvet failed to establish and follow adequate quality control practices, including failing to review batches of drugs made by a contract manufacturer.
“You are ultimately responsible for approving or rejecting drug product batches manufactured for you by a contract facility. Our inspection found that your firm was not performing final reviews of each batch to determine its disposition,” FDA writes.
While Vilvet told FDA it will “develop and/or enhance written procedures for the review and assessment of executed batch records for release,” FDA says the company did not provide details about the new procedures or say when they will be implemented.
FDA also cited the company for having insufficient written procedures for other quality control-related issues, including how the company handles notifications from its supplier regarding process changes and how it oversees complaints made to its telephone hotline.
“However, you lacked procedures to handle and oversee complaints such as quality and adverse events, including how you would refer complaints to your supplier to investigate,” FDA writes.
FDA also says the company did not have procedures in place detailing how it handles out-of-specification or out-of-trend results from its supplier.
Additionally, FDA says the company distributed two unnamed drug products within the US that were not listed with the agency as required under section 510 of the Food, Drug and Cosmetic Act.
On top of the GMP violations for Vilvet’s drug products, FDA says the company failed to follow labeling requirements for two of its dietary supplements, VIL-DHA capsules and VIL-Rx tablets. Some of the issues cited include failing to include a statement identifying VIL-Rx as a dietary supplement, failing to follow formatting requirements and lacking percent daily value information for pregnant or lactating women despite using the terms “prenatal” and “prenatal/postnatal” on the packaging.


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