Vita Pharmacy, LLC dba Talon Pharmacy of Boerne
Form 483 issued February 11, 2020 · Boerne, Texas
- Inspection
- Jan 22 – Feb 11, 2020
- Investigators
- Ana-Maria A. Plapcianu· Clifton L. Randell· Stephen D. Brown
- Observations
- 6
- Pages
- 3
- FEI number
- 3015826784
In short: On February 11, 2020, 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 Jan 22 – Feb 11, 2020. The investigators were Ana-Maria A. Plapcianu, Clifton L. Randell and Stephen D. Brown. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
4 of 6 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.113 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
In regard to aseptic…
- 02
The glass beakers used in the production of sterile, injectable drug products are not depyrogenated prior…
- 03
On 1/24/20, 1 (Stephen Brown) observed brownish residue on a corner of the HEPA filter located…
- 04
In regard to the latest clean room certification dated 10/3/19: A. The ISO 5 classified area…
This inspection in context
Ana-Maria A. Plapcianu
4 documents · 2020–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in California.
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 211.113
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 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Vita Pharmacy, LLC dba Talon Pharmacy of Boerne?
Ana-Maria A. Plapcianu, Clifton L. Randell and Stephen D. Brown are named on this Form 483, for the inspection of Jan 22 – Feb 11, 2020. 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 Jan 22 – Feb 11, 2020, and the Form 483 is dated February 11, 2020.
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.