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Do These Recent Drug GMP Warning Letters Signal A Shift In FDA Enforcement Focus

Do These Recent Drug GMP Warning Letters Signal A Shift In FDA Enforcement Focus?
The FDA’s posting of drug GMP warning letters citing product adulteration has substantially decreased in the past several months. Warning letters are generally issued approximately seven months after inspections. The decrease we are now seeing is due to the slowdown of on-site inspections with COVID travel limitations and concerns regarding investigator safety.
However, the FDA recently posted two unique warning letters that all pharmaceutical and API firms, regardless of their product category, should consider and evaluate. These first-of-a-kind warning letters often signal a new enforcement focus or process for the FDA. (For example, when the FDA issued a warning letter to McKesson Corp. in Feb. 2019, it was the first and so far, the only time the agency cited failure to comply with the requirements in the November 2013 Drug Supply Chain Security Act (DSCSA) amendments to the Food, Dr ....

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Central Maine business briefs: Rangeley organization announces leadership changes

People & Places: Shane Savage named CMGC 2020 Developer of the Year.
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Rangeley Health and Wellness board of directors has announced that Leslie White, MPH, RD, LDN, CSOWM, has been named its executive director. She will assume her new role Jan. 4. Her leadership begins at a critical time for the community and in RHW’S 27-year history. White will succeed Jeanne Thorvaldsen, who is transitioning to a part-time role as RHW’s development director, according to a news release from the organization.
Leslie White, left, and Jeanne Thorvaldsen.
Photo courtesy of RHW
White has been serving as the organization’s deputy director since January. Prior to her tenure at RHW, she worked in a variety of nonprofit settings, in both direct clinical care, and as a healthcare administrator in both Maine and in Pennsylvania. ....

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