Warning Letter: Diversified Manufacturing

November 9, 2005
Pharmaceutical Technology Editors

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.