Geneva Woods Pharmacy
Form 483 issued December 7, 2018 · Anchorage, Alaska
- Inspection
- Nov 26 – Dec 7, 2018
- Investigator
- Stephanie A. Slater
- Observations
- 7
- Pages
- 5
- FEI number
- 3014943990
In short: On December 7, 2018, FDA issued a Form 483 with 7 observations to Geneva Woods Pharmacy in Anchorage, Alaska (FEI 3014943990) after an inspection that ran Nov 26 – Dec 7, 2018. The investigator was Stephanie A. Slater. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
6 of 7 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (4×) · 211.28 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel engaged in aseptic processing were observed with exposed…
- 02
Personnel donned gowning apparel improperly, in a way that may have caused the gowning…
- 03
Your facility design allowed the influx of poor quality air into…
- 04
Disinfecting agents and used in the ISO 5 classified aseptic processing…
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 firmGeneva Woods Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Geneva Woods Pharmacy?
FDA listed 7 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Geneva Woods Pharmacy?
Stephanie A. Slater is named on this Form 483, for the inspection of Nov 26 – Dec 7, 2018. Each investigator has a profile showing what they cite most.
When was Geneva Woods Pharmacy inspected by FDA?
The inspection ran Nov 26 – Dec 7, 2018, and the Form 483 is dated December 7, 2018.
How do I get the full Form 483 for Geneva Woods 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.