05-18-2017 09:40 AM
We run a 503B outsourcing facility and currently send our environmental and personnel monitoring plates to an outside lab to be incubated and read.
Would there be any issue or conflict of interest from the FDA if we have calibrated and monitored incubators to incubate in house and have one of our own personnel (maybe in the quality assurance unit) read the plates? Also, a side question, does anyone know if there is any certification required to be able to read these plates?
Thanks in advance