Warning Letter: Diversified Manufacturing

News
Article

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.

Recent Videos
Drug Digest: Strategic Partnerships
Michelle Bridenbaker from Unbiased Science discusses her thoughts on the key industry from 2024 and those she anticipates will impact the industry in 2025 and beyond.
Henny Zijlstra from Adragos Pharma chats about the trends affecting the outsourcing market, various strategies being employed by service providers, and the value of end-to-end services.