> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Recent PharMedium Inspection Finds Repeat GMP Deviations
- URL: https://www.fdaweb.com/recent-pharmedium-inspection-finds-repeat-gmp-deviations/
- Published: 2018-01-19T12:00:00.000Z
- Updated: 2026-09-14T23:15:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140551

A just-concluded FDA inspection at PharMedium’s Cleveland, MS manufacturing facility has cited the company for repeated inspectional observations from earlier agency inspections, according to a new[ Form 483](https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM592861?ref=fdaweb.com). For example, the firm was cited over its procedures designed to prevent microbiological contamination of drug products purporting to be sterile that are not established, written, and followed. The Form 483 notes that this is a repeat observation from 2013 and 2015 inspections.

Another repeat finding cited equipment and utensils that are not maintained at appropriate intervals to prevent contamination, the agency document says. Additionally, it cited a repeat finding on aseptic processing areas that are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.