FDA 483 - Duren's Health Mart Pharmacy - November 14, 2018

This FDA Form 483 was issued to Duren's Health Mart Pharmacy, a producer of non-sterile drugs, located at 215 Dexter L. Woods Memorial Blvd, Waynesboro, TN 38485. The inspection was conducted on November 6-7, 2018, and November 14, 2018. The report was issued to Jerry M. Duren, Owner, by Investigator Brandon C. Heitmeier on November 14, 2018.

Two observations were made:

1. The firm released drug products where the strength, purity, or quality differed from what was represented. Specifically, expired bulk active pharmaceutical ingredients (APIs) were used in production. Examples include Estriol Vaginal Cream 0.5mg/ml made/dispensed on 03/21/18 and 09/06/18 using API expired 03/05/2018; Domperidone 10mg Capsules made/dispensed on 09/23/18 using API expired 11/30/2016; and Omeprazole 2mg/ml suspension made/dispensed on 08/06/18 and 09/07/18 using API expired 02/2018.

2. Hazardous