LNK Rapped for Unsanitary Processing Conditions

Dirty equipment and a leaky water system led to a Form 483 for drugmaker LNK International.

The agency discovered during a January inspection of its Hauppauge, N.Y., facility, that blenders weren’t properly cleaned.

One blender used for a batch of generic simethicone tablets had pink residue along the hinge on the inner side of the blender lid, reads the form with eight observations. However, simethicone is a white powder.

“Additional pink powder was observed on exterior surfaces of the blender and on the utility panel in the room,” the FDA said.

The blender was used for an earlier product comprised of pink powder. “Between the batches, a major cleaning was documented to have been performed and checked by quality assurance; however, the cleaning did not completely remove residues from the previous product,” the agency noted.

The FDA also found issues with the facility’s purified water system. Investigators found leaks in parts of the system and tape on a product contact surface on the chute of a metal detector.

Proper sanitation is high on the list of issues your employees should be concerned about. If you’re not sure you’ve got sanitation under control or you’ve received an FDA warning letter, sign up for the Ninth Annual FDA Inspections Summit, coming up in October. You’ll be glad you did.