Home > Newsletters > The QMN Weekly Bulletin > Quality Qualms, Inspection Halt Spur Warning for Chinese OTC Drugmaker
The QMN Weekly Bulletin
Nov. 2, 2012 | Vol. 4 No. 44
Quality Qualms, Inspection Halt Spur Warning for Chinese OTC Drugmaker
Fercy Personal Care Products, a Chinese OTC drugmaker, has been warned for a host of quality problems at its Jinhua, China, facility and for limiting investigators’ access to the unregistered plant.
The company stopped the inspection short by at least three days, so the FDA could not complete its walkthrough of the facility and obtain contact information for Fercy suppliers, the recently posted warning letter states.
“These unreasonable delays or denials … give the appearance that your products do not meet U.S. regulations and standards,” the agency said. Prior to the March inspection, the company asked that it be cancelled, the letter also notes.
The FDA asked the company to provide it with a rationale for ending the inspection prematurely.
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