North Carolina API Manufacturer Cited for Serious GMP Failures
The FDA hit API and repackaging facility Giles Chemical of Waynesville, N.C., with a lengthy Form 483 for multiple violations including the use of “reclaimed water” in manufacturing API products.
In a repeated observation from a previous inspection, the FDA investigator witnessed production workers shoveling piles of magnesium sulfate API slurry from the floor into bins used for nonconforming API material.
The slurry was contaminated with “reclaimed water” — water taken from the floor and recycled from drains — that was not tested to prove its suitability for manufacturing APIs. The slurry wasn’t assessed by the quality unit or approved for reuse before processing.