Warning Letter of the Week: vermin edition

In a letter to the general manager of Optum Infusion Services, this observation: 

The FDA investigator noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigator observed that:

1. You did not perform adequate product evaluation and take appropriate corrective action after vermin was observed in your production area. Vermin are a source of microbial contamination. Therefore, your products intended to be sterile were produced in an environment that may not provide adequate protection against the risk of contamination.

Seems bad for a compounding pharmacy!