Geneva Woods Pharmacy, Inc. dba Geneva Woods Pharmacy
Form 483 issued April 9, 2019 · Anchorage, Alaska
- Inspection
- Apr 10, 2017 – Apr 9, 2019
- Investigator
- Kristin M. Abaonza
- Observations
- 2
- Pages
- 2
- FEI number
- 3002759569
In short: On April 9, 2019, FDA issued a Form 483 with 2 observations to Geneva Woods Pharmacy, Inc. dba Geneva Woods Pharmacy in Anchorage, Alaska (FEI 3002759569) after an inspection that ran Apr 10, 2017 – Apr 9, 2019. The investigator was Kristin M. Abaonza. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Beta-lactam chugs were produced without providing adequate containment, cleaning of work surfaces, utensils/equipment and personnel…
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Kristin M. Abaonza
12 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmGeneva Woods Pharmacy, Inc. dba Geneva Woods Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Geneva Woods Pharmacy, Inc. dba Geneva Woods Pharmacy?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Geneva Woods Pharmacy, Inc. dba Geneva Woods Pharmacy?
Kristin M. Abaonza is named on this Form 483, for the inspection of Apr 10, 2017 – Apr 9, 2019. Each investigator has a profile showing what they cite most.
When was Geneva Woods Pharmacy, Inc. dba Geneva Woods Pharmacy inspected by FDA?
The inspection ran Apr 10, 2017 – Apr 9, 2019, and the Form 483 is dated April 9, 2019.
How do I get the full Form 483 for Geneva Woods Pharmacy, Inc. dba 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.