Fairview Pharmacy Services, LLC
Form 483 issued April 18, 2018 · Minneapolis, Minnesota
- Inspection
- Apr 2 – Apr 18, 2018
- Investigators
- Anthony Ladner· Tenzin Jangchup
- Observations
- 6
- Pages
- 4
- FEI number
- 3013468187
In short: On April 18, 2018, FDA issued a Form 483 with 6 observations to Fairview Pharmacy Services, LLC in Minneapolis, Minnesota (FEI 3013468187) after an inspection that ran Apr 2 – Apr 18, 2018. The investigators were Anthony Ladner and Tenzin Jangchup. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
6 of 6 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (6×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Non-sterilized and Non-depyrogenated equipment was used…
- 02
The use of sporicidal agents in the cleanrooms and ISO 5 classified aseptic…
- 03
Personnel did not disinfect and change gloves frequently…
- 04
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing…
This inspection in context
Anthony Ladner
10 documents · 2016–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
The firmFairview Pharmacy Services, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Fairview Pharmacy Services, LLC?
FDA listed 6 observations on this Form 483, mostly about production. 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 Fairview Pharmacy Services, LLC?
Anthony Ladner and Tenzin Jangchup are named on this Form 483, for the inspection of Apr 2 – Apr 18, 2018. Each investigator has a profile showing what they cite most.
When was Fairview Pharmacy Services, LLC inspected by FDA?
The inspection ran Apr 2 – Apr 18, 2018, and the Form 483 is dated April 18, 2018.
How do I get the full Form 483 for Fairview Pharmacy Services, LLC?
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.