Hello, I believe that I read a post on the use of certain types of pens a while back, but I could not find it again. The FDA requirement in 820.180 Records stipulates that "records shall be legible and shall be stored to minimize deterioration" which auditors have interpreted to mean that the writing implement ink cannot degrade over the life of the record. I have found reference to a "felt pen" and similar in FDA webpages, but no EIRs, 483's or warning letters that identify the use of other than indelible ink pens is required. Does anyone have any further insights?
Good one AL...many years ago the AF inspector at Fairchild Republic insisted all signatures had to be in blue ink so you could tell it was an original. I guess color copiers weren't available in Farmingdale, LI.
Thanks Mary, I try. BTW, having also worked there for some years, I know that they are a little behind in Farmingdale.