American Pharmacy of Illinois Inc. dba Alwan's Pharmacy
Form 483 issued October 28, 2015 · Peoria, Illinois
- Inspection
- Sep 9 – Oct 28, 2015
- Investigator
- Christina A. Miller
- Observations
- 14
- Pages
- 7
- FEI number
- 3008688061
In short: On October 28, 2015, FDA issued a Form 483 with 14 observations to American Pharmacy of Illinois Inc. dba Alwan's Pharmacy in Peoria, Illinois (FEI 3008688061) after an inspection that ran Sep 9 – Oct 28, 2015. The investigator was Christina A. Miller. 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 10 of 14 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The control systems necessary to prevent contamination…
- 02
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 03
Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature is not provided when…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Christina A. Miller
10 documents · 2010–2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Illinois.
The firmAmerican Pharmacy of Illinois Inc. dba Alwan's Pharmacy history
All 3 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 American Pharmacy of Illinois Inc. dba Alwan's Pharmacy?
FDA listed 14 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 American Pharmacy of Illinois Inc. dba Alwan's Pharmacy?
Christina A. Miller is named on this Form 483, for the inspection of Sep 9 – Oct 28, 2015. Each investigator has a profile showing what they cite most.
When was American Pharmacy of Illinois Inc. dba Alwan's Pharmacy inspected by FDA?
The inspection ran Sep 9 – Oct 28, 2015, and the Form 483 is dated October 28, 2015.
How do I get the full Form 483 for American Pharmacy of Illinois Inc. dba Alwan's 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.