After conducting an inspection of Zeller Power Products’ medical device operations, the FDA concluded that the firm was not compliant with the US GMP requirements under 21 CFR 820 Quality System Regulations.

FDA issues the first warning letter for UDI violations

On May 9, 2019, a Warning Letter was issued by the FDA because the specific violations noted in the FDA Form 483 / Inspectional Observations issued at the close of the inspection on November 9, 2018 were not addressed properly by the manufacturer.

The violations included, but were not limited to:

  • Failure to ensure that the label of every medical device bears a Unique Device Identifier (UDI) that meets the requirements of 21 CFR 801 Subpart B and 21 CFR 830, as required by 21 CFR 801.20(a). Class III devices manufactured and labeled after September 24, 2014, must bear an UDI, unless an exception or alternative applies.
  • Failure to provide the required information to Global Unique Device Identification Database (GUDID) as required by 21 CFR 830.300(a). Labelers of devices required to bear an UDI are required to submit specific data pertaining to these devices to FDA’s GUDID on or before September 24, 2014.

Zeller Power Products, LLC was urged to investigate and determine the causes of the violations and take prompt actions to correct them, thus bringing their products into compliance.