Talon Compounding Pharmacy
Form 483 issued June 24, 2015 · San Antonio, Texas
- Inspection
- Jun 15 – Jun 24, 2015
- Investigators
- Darla J. Christopher· Unnee Ranjan
- Observations
- 10
- Pages
- 5
- FEI number
- 3009192575
In short: On June 24, 2015, FDA issued a Form 483 with 10 observations to Talon Compounding Pharmacy in San Antonio, Texas (FEI 3009192575) after an inspection that ran Jun 15 – Jun 24, 2015. The investigators were Darla J. Christopher and Unnee Ranjan. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 6 of 10 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
- 03
There is no written testing program designed to assess the stability…
- 04
Clothing of personnel engaged in the processing of drug products is not appropriate for…
This inspection in context
Darla J. Christopher
10 documents · 2010–2020
Cites 211.42 (design and construction features) 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Talon Compounding Pharmacy?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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?
Darla J. Christopher and Unnee Ranjan are named on this Form 483, for the inspection of Jun 15 – Jun 24, 2015. Each investigator has a profile showing what they cite most.
When was Talon Compounding Pharmacy inspected by FDA?
The inspection ran Jun 15 – Jun 24, 2015, and the Form 483 is dated June 24, 2015.
How do I get the full Form 483 for Talon Compounding Pharmacy?
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