FDA has released a copy of the 483 document that it sent May 15 to Bausch & Lomb VP of Operations Thomas Eggleton, detailing "objectionable conditions" within the Greenville, S.C. plant where ReNu with MoistureLoc has been manufactured. If you haven't been following the news, the company has pulled the product from store shelves due to allegations that it leads to fungal infections in users. FDA cited the facility for, among other things: improper revalidation procedures following process deviatiions, failure to notify FDA of injury reports, and even peeling paint in a mixing room.
The document makes for interesting reading, but the reproduction is far from good--you'll need your reading glasses.
-- PWT
