
Originally Posted by
APIs
Having worked in Pharma for over 25 years I wouldnt be overly concerned about this and I actually use them for certain meds. These reports are referred to as 483s and reference what inspectors consider to be poor manufacturing standards found during an on-site inspection. In the grand scope of things, these particular observations appear to be rather minor, as I have seen much worse in my career. It's not uncommon for FDA to find something during such an inspection and nothing comes of it if the matters are addressed. FDA will thoroughly follow up on these findings & all corrections must be fully documented to their complete satisfaction. If their facility was truly a mess, they would not be open for business right now. If there were serious violations, FDA would move to have them shut down and would publish such action(s) on their website for the public to see...