Civic Center Pharmacy
Form 483 issued March 30, 2017 · Scottsdale, Arizona
- Inspection
- Mar 21 – Mar 30, 2017
- Investigator
- Stephanie A. Slater
- Observations
- 5
- Pages
- 2
- FEI number
- 3005144312
In short: On March 30, 2017, FDA issued a Form 483 with 5 observations to Civic Center Pharmacy in Scottsdale, Arizona (FEI 3005144312) after an inspection that ran Mar 21 – Mar 30, 2017. The investigator was Stephanie A. Slater. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 4 of 5 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel were observed using a non-sterile tool or manually contact the inner surface…
- 02
There is inadequate HEPA filter coverage or airflow over the area to which…
- 03
The fmal containers/closures used for drug product intended to be sterile have not been…
- 04
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
This inspection in context
Stephanie A. Slater
20 documents · 2015–2021
Cites 211.67 (equipment cleaning and maintenance) 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Civic Center Pharmacy?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and materials. 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?
Stephanie A. Slater is named on this Form 483, for the inspection of Mar 21 – Mar 30, 2017. Each investigator has a profile showing what they cite most.
When was Civic Center Pharmacy inspected by FDA?
The inspection ran Mar 21 – Mar 30, 2017, and the Form 483 is dated March 30, 2017.
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.