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Posted 14 August 2013 | By Alexander Gaffney, RAC,
Do-it-yourself fixes are a point of pride for many, from knowledgeable handymen to frugal college students. Gutters on your house leaking? Nothing some tack welding can't fix. Rubber hose in your car sprung a leak? A quick patch with some duct tape will do in a pinch.
But as a new Warning Letter from the US Food and Drug Administration (FDA) to a dietary supplement manufacturer illustrates, shoddy DIY isn't compatible with current good manufacturing processes (CGMP).
The letter, sent 22 July 2013 to N.V.E. Pharmaceuticals, referenced a September 2012 inspection of the company's manufacturing facility in Andover, N.J.
That inspection yielded a number of alarming observations, FDA said in its letter, including pipes located above an ingredient mixer that were "covered with an unknown crystallized residue" and were leaking condensation directly into the mixer.
But just as alarming was the company's use of unorthodox fixes to certain manufacturing equipment. FDA alleges in the Warning Letter that an encapsulator was "repaired in various locations using clear tape, aluminum foils, and rubber bands."
In another instance, two portable capsule dedusters "were repaired using cardboard, clear tape and rubber bands."
Other violations alleged in the letter:
Warning Letter to NVE Pharmaceuticals
Tags: Dietary Supplement, warning letter, Latest News, cGMP
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