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483
•Rhodes Technologies•July 27, 2016

Rhodes Technologies – FDA 483, Jul 27, 2016

Record Details

An FDA inspection of Rhodes Technologies in Coventry, RI, revealed significant deficiencies in the firm's Quality Unit operations. Observations included failures to identify unknown peaks during residual solvent analysis, inadequate investigation of out-of-specification microbial content results, and multiple failures to adequately investigate deviations related to their stability program. These issues highlight systemic problems in quality control and investigation processes.

Company
Rhodes Technologies
Inspection date
July 27, 2016
Product type
drugs
Office
Division of Northeast Imports 
Person
  • Erik W. Koester (Investigator)
View Company Profile

ID · 52f63025-0aa7-44ff-af28-cb1cdf793e3c

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