FDA EIR - Kareway Product Inc - March 28, 2019

Kareway Product, Inc., located in Rancho Dominguez, CA, underwent an FDA inspection from March 25 to March 28, 2019. This inspection was part of a routine surveillance under the Center for Drug Evaluation and Research's (CDER) post-marketing adverse drug experience (PADE) compliance program. The focus was on the post-marketing surveillance of over-the-counter (OTC) monograph drugs and associated adverse drug experience reporting.

The inspection revealed no prior FDA inspection history or warnings for Kareway Product, Inc. However, the firm had previously initiated a Class 2 recall for an allergy medicine in 2013 and a Class 1 recall for an eye wash in 2017. During the inspection, records reviewed included complaint-handling standard operating procedures, recall documentation, and adverse drug experience reports from customers and consumers.

The main issues identified were related to the firm's procedures for handling complaints and reporting adverse drug experiences. The inspection found deficiencies in the firm's written procedures and the maintenance of complaint files. The firm was advised to enhance its complaint handling and adverse event reporting processes to comply with FDA requirements.

Kareway Product, Inc. is required to address these deficiencies by revising its standard operating procedures and improving its record-keeping practices to ensure compliance with the regulatory framework governing OTC monograph drugs. The firm must also ensure timely and accurate reporting of adverse drug experiences to the FDA.