ORGANIZATION AND PERSONNELI suspect that this is one of those things that happens pretty much every day in many biopharma manufacturing plants around the world -- but this day, there happened to be an FDA inspector watching. Oops.
12) Employees are not adequately trained. For example:
a. An employee dressed in an animal control uniform walked through the production gowning area without stopping to gown, and sidestepped three “antibacterial adhesive rugs” as he walked through the gowning area. He failed to follow SOP #P-PB-052, Plant Access Control, section D4.
b. An operator working in the fractionation Area had his facemask pulled down while having a conversation with another operator in the area. All employees must wear masks while working in the fractionation area as required by SOP P-PB-052.
Wednesday, April 30, 2014
Warning Letter of the Week: Step ON the antibacterial rugs
From the FDA's warning letters feed, a missive to Instituto Bioclon S.A. de C.V., located in Mexico City. Among other findings, this little gem: