Day

July 23, 1997
23
Jul

Biomet Ltd.

July 23, 1997
3. Failure to assure that specification changes shall be subject to controls as stringent as those applied to the original device, as required by 21 CFR 820.100(a)(2). This would also be a violation of the Quality System Regulation, 21 CFR 820.70(i). For example, no documentation of specific software changes, which were made to the _____...
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