Padtest, LLC – FDA Warning Letter, Oct 8, 2014

On December 17, 2014, the FDA issued a Warning Letter to Padtest, LLC, following an inspection from September 16 to October 8, 2014, at their Scottsdale, Arizona facility, which manufactures PADCHEK? devices. The inspection revealed the devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to provide required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting).

Key violations include: 1. Failure to establish purchasing control procedures (21 CFR 820.50). 2. Failure to establish design control procedures (21 CFR 820.30(a)). 3. Failure to establish corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)). 4. Inadequate maintenance of a device master record (21 CFR 820.181). 5. Failure to establish acceptance activity procedures (21 CFR 820.80(a)). 6