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FDA Warning Letter about Deviation from USP Compendial Methods
Автор: Learn with Bappa
Загружено: 2023-07-22
Просмотров: 25
Описание:
The U.S. Food and Drug Administration (FDA) has published a Warning Letter dated April 14, 2022. This Warning Letter goes back to an inspection from September 20 to September 24, 2021. The firm's response to the FDA 483 issued after the inspection was considered inadequate by the FDA "because it did not provide sufficient detail or evidence of corrective actions to bring [the] operations into compliance with CGMP."
The product in focus is Mint Gel Topical Anesthetic, a United States Pharmacopeia (USP) article manufactured by Cetylite Industries, Inc., an American firm located in New Jersey.
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