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:
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.
Which makes it even worse. If they are that lax when the FDA is around, what are they doing when they aren't?
ReplyDeleteDuring my time in GMP, EMAILs would fly whenever the FDA was in the building, or heading that way. We were told to keep all conversations to a minimum, in the facility, in the hallway, in the bathroom, so they wouldn't overhear something that could be damaging. It was all out lock-down mode when they were walking about....
Sidestepping 3 rugs? Could it be that management is trying to hold costs down by prolonging the life of the rugs and telling everyone NOT to use them properly?
ReplyDeleteI'm open to alternative explanations
Those mats are kind of annoying to step on, there's a bit of a pull on your foot, which might slow your pace. If it annoyed me enough, I might avoid them. Who knows?
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