Mayo Clinic Pharmacy
Form 483 issued August 15, 2018 · Rochester, Minnesota
- Inspection
- Aug 6 – Aug 15, 2018
- Investigators
- James K. Ireland· Tenzin Jangchup
- Observations
- 5
- Pages
- 3
- FEI number
- 3005070479
In short: On August 15, 2018, FDA issued a Form 483 with 5 observations to Mayo Clinic Pharmacy in Rochester, Minnesota (FEI 3005070479) after an inspection that ran Aug 6 – Aug 15, 2018. The investigators were James K. Ireland and Tenzin Jangchup. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 3 of 5 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
- 02
Non-microbial contamination was observed…
- 03
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing…
- 04
Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were…
This inspection in context
James K. Ireland
10 documents · 2016–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
The firmMayo Clinic Pharmacy 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 Mayo Clinic Pharmacy?
FDA listed 5 observations on this Form 483, mostly about production, quality system 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 Mayo Clinic Pharmacy?
James K. Ireland and Tenzin Jangchup are named on this Form 483, for the inspection of Aug 6 – Aug 15, 2018. Each investigator has a profile showing what they cite most.
When was Mayo Clinic Pharmacy inspected by FDA?
The inspection ran Aug 6 – Aug 15, 2018, and the Form 483 is dated August 15, 2018.
How do I get the full Form 483 for Mayo Clinic 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.