Vita Pharmacy, LLC dba Talon Pharmacy of Boerne
FDA inspection history across 3 sites, 2020 to 2023
- 3
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2020: one Form 483; 2021: one Form 483; 2022: one warning letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–23Three Form 483s and one warning letter, at Boerne, Texas and Austin, Texas.
- 2021The longest 483 on file: 6 observations over 3 pages at Boerne, Texas.
Cited most
Across all Vita Pharmacy, LLC dba Talon Pharmacy of Boerne observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.42Design and construction features5
- 21 CFR 211.67Equipment cleaning and maintenance4
- FDCA 501(a)(2)(A)Insanitary conditions3
- 21 CFR 211.56Sanitation1
The complete Vita Pharmacy, LLC dba Talon Pharmacy of Boerne file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Boerne, Texas
Three Form 483s · 2020 to 2023 · 16 observations
Latest: Form 483, Sep 8, 2023 →Austin, Texas
One warning letter · 2022
Latest: Warning letter, Aug 29, 2022 →Gilbert, Arizona
One close-out letter
Latest: Close-out, — →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-08 | 483 Form 483 | Boerne, Texas | 4 | $99 |
| 2022-08-29 | Warning letter Warning letter | Austin, Texas | — | $99 |
| 2021-11-02 | 483 Form 483 | Boerne, Texas | 6 | $99 |
| 2020-02-11 | 483 Form 483 | Boerne, Texas | 6 | $99 |
| Undated | Close-out Close-out letter | Gilbert, Arizona | — | $99 |
Investigators on these documents
Stephen D. Brown (2)Ana-Maria A. Plapcianu (1)Camerson E. Moore (1)Clifton L. Randell (1)
FEI number 3015826784 · most recent document Sep 8, 2023
About Vita Pharmacy, LLC dba Talon Pharmacy of Boerne
How many FDA Form 483s has Vita Pharmacy, LLC dba Talon Pharmacy of Boerne received?
FDA Intel has 3 Form 483s on file for Vita Pharmacy, LLC dba Talon Pharmacy of Boerne; the most recent is dated Sep 8, 2023.
When was Vita Pharmacy, LLC dba Talon Pharmacy of Boerne last inspected by FDA?
The most recent FDA inspection document on file for Vita Pharmacy, LLC dba Talon Pharmacy of Boerne is a Form 483 dated Sep 8, 2023, for the site in Boerne, Texas.
What did FDA cite at Vita Pharmacy, LLC dba Talon Pharmacy of Boerne?
The regulations cited most in the observations on file for Vita Pharmacy, LLC dba Talon Pharmacy of Boerne are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.42 (Design and construction features), 5 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times.
Has Vita Pharmacy, LLC dba Talon Pharmacy of Boerne received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Vita Pharmacy, LLC dba Talon Pharmacy of Boerne; the most recent is dated Aug 29, 2022.