Duren's Health Mart Pharmacy – FDA 483, Nov 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
- Company
- Duren's Health Mart Pharmacy
- Inspection date
- November 14, 2018
- Product type
- Drugs
- Person
ID · 668300bc-743a-42bf-a860-da95f3f70b79
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.