Vita Pharmacy, LLC dba Talon Pharmacy of Boerne

Form 483 issued September 8, 2023 · Boerne, Texas

Inspection
Sep 8, 2023
Investigator
Camerson E. Moore
Observations
4
Pages
4
FEI number
3015826784

In short: On September 8, 2023, FDA issued a Form 483 with 4 observations to Vita Pharmacy, LLC dba Talon Pharmacy of Boerne in Boerne, Texas (FEI 3015826784) after an inspection that ran Sep 8, 2023. The investigator was Camerson E. Moore. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).

At a glance

Observations span 1 system, led by facilities & equipment.

Facilities & equipment1
Other3

Most cited: FDCA 501(a)(2)(A) (3×) · 211.67 (1×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    FDCA 501(a)(2)(A)

    The facility design was observed to allow the influx of lesser quality air into a classified…

  2. 02
    FDCA 501(a)(2)(A)

    Personnel performed aseptic manipulations with…

  3. 03
    FDCA 501(a)(2)(A)

    Failure to appropriately and regularly clean and disinfect or sterilize equipment located in…

  4. 04

    Observation 4: scanned text, readable in the full document.

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

Questions about this 483

What did FDA find at Vita Pharmacy, LLC dba Talon Pharmacy of Boerne?

FDA listed 4 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.

Who inspected Vita Pharmacy, LLC dba Talon Pharmacy of Boerne?

Camerson E. Moore is named on this Form 483, for the inspection of Sep 8, 2023. 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 Sep 8, 2023, and the Form 483 is dated September 8, 2023.

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.

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