Vita Pharmacy, LLC dba Talon Pharmacy of Boerne
Form 483 issued November 2, 2021 · Boerne, Texas
- Inspection
- Nov 2, 2021
- Investigator
- Stephen D. Brown
- Observations
- 6
- Pages
- 3
- FEI number
- 3015826784
In short: On November 2, 2021, FDA issued a Form 483 with 6 observations to Vita Pharmacy, LLC dba Talon Pharmacy of Boerne in Boerne, Texas (FEI 3015826784) after an inspection that ran Nov 2, 2021. The investigator was Stephen D. Brown. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
4 of 6 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (3×) · 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your facility design may allow the influx of poor quality air into…
- 02
You produced hazardous drugs without providing adequate containment and…
- 03
On 10/27/2021, I observed a dark residue on the plastic grille enclosing the HEPA filter located…
- 04
Materials and supplies were not disinfected pdor to entering…
This inspection in context
Stephen D. Brown
42 documents · 2006–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmVita Pharmacy, LLC dba Talon Pharmacy of Boerne history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vita Pharmacy, LLC dba Talon Pharmacy of Boerne?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Vita Pharmacy, LLC dba Talon Pharmacy of Boerne?
Stephen D. Brown is named on this Form 483, for the inspection of Nov 2, 2021. Each investigator has a profile showing what they cite most.
When was Vita Pharmacy, LLC dba Talon Pharmacy of Boerne inspected by FDA?
The inspection ran Nov 2, 2021, and the Form 483 is dated November 2, 2021.
How do I get the full Form 483 for Vita Pharmacy, LLC dba Talon Pharmacy of Boerne?
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.