Talon Compounding Pharmacy
Form 483 issued July 26, 2018 · San Antonio, Texas
- Inspection
- Jul 26, 2018
- Investigator
- Camerson E. Moore
- Observations
- 8
- Pages
- 4
- FEI number
- 3009192575
In short: On July 26, 2018, FDA issued a Form 483 with 8 observations to Talon Compounding Pharmacy in San Antonio, Texas (FEI 3009192575) after an inspection that ran Jul 26, 2018. The investigator was Camerson E. Moore. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 3 systems, led by facilities & equipment.
Most cited: FDCA 501(a)(2)(A) (4×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Your facility design allowed the influx of poor quality air into…
- 02FDCA 501(a)(2)(A)
Personnel engaged in aseptic processing were…
- 03FDCA 501(a)(2)(A)
EMPLOYEE($) SIGNATURE DATE lSSUEO Personnel did not…
- 04FDCA 501(a)(2)(A)
Equipment was not disinfected prior to entering the…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmTalon Compounding Pharmacy history
All 4 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 Talon Compounding Pharmacy?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and packaging & labeling. 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 Talon Compounding Pharmacy?
Camerson E. Moore is named on this Form 483, for the inspection of Jul 26, 2018. Each investigator has a profile showing what they cite most.
When was Talon Compounding Pharmacy inspected by FDA?
The inspection ran Jul 26, 2018, and the Form 483 is dated July 26, 2018.
How do I get the full Form 483 for Talon Compounding 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.