Civic Center Pharmacy
Form 483 issued October 9, 2014 · Scottsdale, Arizona
- Inspection
- Sep 10 – Oct 9, 2014
- Investigator
- Joey V. Quitania
- Observations
- 2
- Pages
- 3
- FEI number
- 3005144312
In short: On October 9, 2014, FDA issued a Form 483 with 2 observations to Civic Center Pharmacy in Scottsdale, Arizona (FEI 3005144312) after an inspection that ran Sep 10 – Oct 9, 2014. The investigator was Joey V. Quitania. 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 2 of 2 observations.
Most cited: 21 CFR 211.42(c)(10)(iv) (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas re deficient regarding the system for monitoring environmental conditions. Specitically, Environmental Monitoring of…
- 02
Specifica lly. a) There are t::>!.<~ul ~:>l written procedures . However. SOP 8.030, Vers 1.0, "Sterilization…
This inspection in context
Joey V. Quitania
23 documents · 2009–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmCivic Center Pharmacy history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Civic Center Pharmacy?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. 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 Civic Center Pharmacy?
Joey V. Quitania is named on this Form 483, for the inspection of Sep 10 – Oct 9, 2014. Each investigator has a profile showing what they cite most.
When was Civic Center Pharmacy inspected by FDA?
The inspection ran Sep 10 – Oct 9, 2014, and the Form 483 is dated October 9, 2014.
How do I get the full Form 483 for Civic Center 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.