Wednesday, September 28, 2016

Warning Letter of the Week: smelly smells edition

This morning brings us a warm missive from the Food and Drug Administration to Mr. Hung Chih Wu of Cheng Fong Chemical Co., in Taoyuan City. A fairly typical set of findings, but this one is new:
3.    Failure to properly maintain buildings used in the manufacture of API in a clean condition.

For example, our investigator observed filth, insects, wet layers of [redacted] unidentified material on the floors, and foul odors in the cold rooms used to store raw materials and intermediates used in the manufacture of your finished API. Firm officials noted that the rooms had never been cleaned.

We acknowledge your corrective actions, including cleaning, and adding the cold rooms to your pest control program.
Gotta say, "foul odors" is one that I haven't seen before.

(How is that not a discretionary judgment on the part of the inspector? Granted, if you're smelling something rotting, it's probably a prima facie case of your warehousing not being sufficiently clean.) 


  1. Sort of off topic, but I used to work with with some people testing toothpaste additives. They were in the lab next door to me. They used to have to do some tests involving pig tongues. One day I noticed my broken glassware/waste container smelled bad. For a day or two I assumed it was just glassware with traces of amines, but then I realized they were dumping the pig tongues in there. Worst waste container smell ever. I can't even imagine what they were thinking, because the containers only got emptied when full.

    1. Wait, into the glassware waste? Not even the chemical waste in a hood? Really should have gone into a biohaz container. Who the hell are these jokers?