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Avax Receives FDA Warning Letter Regarding Inspection.(Brief Article)
2001 DEC 12 - (NewsRx.com & NewsRx.net) -- Avax Technologies (AVXT) has received a warning letter from the Division of Inspections and Surveillance of the U.S. Food and Drug Administration (FDA).
While AVAX reported to the FDA on June 29, 2001, that the company had initiated corrective actions in response to the observations noted by the FDA inspectors in their Form FDA 483, the Division of Inspections and Surveillance has requested additional information to ensure that the company will operate in full compliance with the applicable FDA regulations.
The warning letter, which relates to the FDA inspection of the company's manufacturing facility in April and May, is an FDA regulatory document notifying the company that the Agency considers certain manufacturing and clinical practices to be in violation of the regulations governing the proper conduct of clinical studies involving investigational new drugs. As specified in all warning letters, failure by the company to take appropriate and prompt action to correct and prevent any future repeat of the deficiencies can result in an administrative or regulatory action.
The company is required to respond within 15 business days of receipt of the warning letter, documenting actions that have been taken and specific actions to be taken going forward. The company may request an extension to ensure the most complete and adequate response possible. Avax had previously retained the services of Don Hill and ...
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Source: HighBeam Research, Avax Receives FDA Warning Letter Regarding Inspection.(Brief Article)