Wednesday, July 20, 2016

Warning Letter of the Week: foreign debris edition

In today's batch of FDA warning letters, one to Sir Andrew Witty, CEO of GSK. It's mostly about penicillin residue in non-penicillin manufacturing areas (that's problematic), but I found this section interesting:
C. Foreign particles found in [redacted] API [redacted]

Your investigation into foreign particles found in [redacted] batch [redacted] identified:
  • green fibers consistent with scouring pads
  • red flakes consistent with paint in the manufacturing plant
  • black particulates consistent with glass particles 
You concluded that these were “acceptable intrinsic” contaminates.

Your response is inadequate. It failed to include a root-cause evaluation of glass particles and the foreign materials found in these drugs. You also failed to evaluate the impact of the contaminants on all other drugs manufactured with the same equipment in the same facility.

In response to this letter, provide a risk assessment for the (b)(4) manufacturing process and other drugs produced with the same equipment. Include an evaluation of the physical condition of your facility and of your cleaning and preventive maintenance procedures for your manufacturing equipment. 
Scouring pads! That's a new one.  


  1. There was a hard had in something we shipped ...

  2. I spoke with LC field engineer who used to work as QC analytical chemist at Glaxo, in process plant making thyroid medication. He swore he would never take the generic stuff they were making because the quality standards were so bad. (He also claimed that he and others were having health issues because of by overexposure to levothyroxine API spilled around the place, and this made him quit)