Duren's Health Mart Pharmacy
Form 483 issued November 14, 2018 · Waynesboro, Tennessee
- Inspection
- Nov 6 – Nov 14, 2018
- Investigator
- Brandon C. Heitmeier
- Observations
- 2
- Pages
- 2
- FEI number
- 3011584827
In short: On November 14, 2018, FDA issued a Form 483 with 2 observations to Duren's Health Mart Pharmacy in Waynesboro, Tennessee (FEI 3011584827) after an inspection that ran Nov 6 – Nov 14, 2018. The investigator was Brandon C. Heitmeier. Most observations concern materials and production; the most-cited regulation is 21 CFR 211.87 (retesting of approved components, drug product containers, and closures).
At a glance
Materials and production account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm released drug product in which the strength differs from, or its purity or quality…
- 02
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or…
This inspection in context
Brandon C. Heitmeier
12 documents · 2009–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Tennessee.
The firmDuren's Health Mart Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.87
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Duren's Health Mart Pharmacy?
FDA listed 2 observations on this Form 483, mostly about materials and production. The most-cited regulation is 21 CFR 211.87 (retesting of approved components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Duren's Health Mart Pharmacy?
Brandon C. Heitmeier is named on this Form 483, for the inspection of Nov 6 – Nov 14, 2018. Each investigator has a profile showing what they cite most.
When was Duren's Health Mart Pharmacy inspected by FDA?
The inspection ran Nov 6 – Nov 14, 2018, and the Form 483 is dated November 14, 2018.
How do I get the full Form 483 for Duren's Health Mart Pharmacy?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.