Warning Letter: Diversified Manufacturing
ePT--the Electronic Newsletter of Pharmaceutical Technology
This week, the US Food and Drug Administration posted an Oct. 20 Warning Letter (http://www.fda.gov/foi/warning_letters/g5567d.htm) sent by its Minneapolis, MN district office to Diversified Manufacturing Corporation (Newport, MN).
This week, the US Food and Drug Administration posted an Oct. 20 Warning Letter (www.fda.gov/foi/warning_letters/g5567d.htm) sent by its Minneapolis (MN) district office to Diversified Manufacturing Corporation (Newport, MN).
The two-page letter cited shortcomings in the company's manufacture of over-the-counter human drugs, including cited failures to validate equipment cleaning and maintain cleaning and maintenance records, especially for mixing vessels used for multiple products. The agency complained that the company did not have quality laboratory confirmation of conformance to specifications before the drug was released. The agency also found failures to investigate out of specification products.
PacBio Chosen as Tech Partner for Global Alzheimer’s Disease Research Project
April 23rd 2025The project, the North African Dementia Registry, will unite multiple entities for the purpose of developing a comprehensive dataset to advance the research community’s understanding of Alzheimer’s disease and other dementias in diverse populations.
