DIY Fixes Don't Meet CGMP: FDA Slams Manufacturer for Fixes Involving Tape, Rubber Bands
Posted 14 August 2013 | By
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).
Rubber Bands, Leaky Pipes, Cardboard and Aluminum Foil
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:
- Walls, ceiling tiles, air ducts and electrical outlet covers were "covered with dust" in one room used to blend ingredients.
- Bottles on the filling lines were "not protected from foreign materials from entering the bottles," including from "residual material located on pipes" above the filling line.
- Rolls of blister cards stock and plastic blister film were observed to be stored on the floor prior to their use in the manufacturing process.
- Chunks of the company's "Stacker 2" capsule blend were observed in a blender on 13 September when that product had last been produced on 5 September.
- A plethora of misbranding violations related to labeling problems, most notable related to improper listing of ingredients (e.g. wrong order, incorrect placement on the label, incorrect formatting, failure to list servings per container, etc).
Warning Letter to NVE Pharmaceuticals