Quality Qualms, Inspection Halt Spur Warning for Chinese OTC Drugmaker

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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.

If you need to stop FDA inspectors midway, your plant might not be in good shape either. Having the right people and documents present at the right time is paramount to a successful inspection.

Next time the FDA comes to your company, who is going to be in your war room and how should you determine assigned roles and seniority? What kinds of information should you provide — and what’s off limits to the FDA?

If you’re a drug- or devicemaker and cannot confidently answer these questions, clear your schedule this Thursday for FDAnews’ Creating, Staffing and Managing an Inspection War Room.

This detailed webinar goes far above where those other basic “how to prepare for inspections” seminars peak. Too often, companies slap together what is essentially the central nervous system of their inspections. Rescheduled due to Hurricane Sandy, you’re in luck to get in one more last-minute registration opportunity for this must-attend webinar. Creating, Staffing and Managing an Inspection War Room will teach you the who, what, where, why and how behind every good inspection. Don’t expect another storm to push this back another week, register today!

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