Warning Letter: Software specifications were not maintained (ucm429201)


Ofni Systems

“A device master record has not been adequately maintained, as required by 21 CFR 820. 181. For example,┬áspecifications for the various components of the device were not maintained; software specifications were not maintained; production process specifications and procedures were not maintained; quality assurance procedures and acceptance criteria were not maintained; packaging and labeling specifications were not maintained; and installation, maintenance and servicing procedures and methods were not maintained.

View the original warning letter .


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