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]]> By: EEJ http://www.pharmalot.com/2007/09/fda-we-cant-inspect-all-those-overseas-plants/#comment-20683 EEJ Thu, 27 Sep 2007 16:36:10 +0000 http://www.pharmalot.com/2007/09/fda-we-cant-inspect-all-those-overseas-plants/#comment-20683 I worked for a worldwide healthcare corporation, in an office/repair shop that fixed class 1 medical devices. When I first started working there, it was away from the main facility across town, and nobody even bothered to wear labcoats or gloves. Anywho, after working there 3 years, I realized that the FDA had never once set foot into our repair shop, although we were repairing infusion pumps, which you would think would be highly regulated. The only "inspections" we ever had were conducted by someone from the company, and my manager always had at least 2 weeks notice before they arrived. Obviously, every time we were inspected everything was found to be performed according to the rules/guidelines..... I worked for a worldwide healthcare corporation, in an office/repair shop that fixed class 1 medical devices.

When I first started working there, it was away from the main facility across town, and nobody even bothered to wear labcoats or gloves.

Anywho, after working there 3 years, I realized that the FDA had never once set foot into our repair shop, although we were repairing infusion pumps, which you would think would be highly regulated. The only “inspections” we ever had were conducted by someone from the company, and my manager always had at least 2 weeks notice before they arrived.

Obviously, every time we were inspected everything was found to be performed according to the rules/guidelines…..

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