Recipient: Perma Pure LLC.
Product: moisture exchange gas dryers
The inspection revealed that your devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. 351(h)) in that the methods used in, or the facilities or controls used for their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation, Title 21 Code of Federal Regulations, Part 820 (21 CFR 820).These violations include, but are not limited to the following:
3. The (b)(4) Calibration Management software has not been validated as required by 21 CFR 820.70(i). This software is used to maintain equipment calibration records and calibration procedures. This same observation was made during the previous inspection of July 2006.
Your response to this observation was not substantively different than your response to observation #2 above regarding process validation. We continue to find your response to be insufficient. Specifically, we cannot determine the adequacy of this response as no document was submitted; we do not consider your response regarding management reviews to be adequate; and the software validation conducted during the recent inspection does not appear to have been conducted per an approved protocol or documented predetermined acceptance criteria.
FDA office: New Jersey District Office