Mayo Clinic PET Radiochemistry Facility
Form 483 issued April 12, 2019 · Jacksonville, Florida
- Inspection
- Apr 9 – Apr 12, 2019
- Investigator
- Libia M. Lugo
- Observations
- 2
- Pages
- 3
- FEI number
- 3014201471
In short: On April 12, 2019, FDA issued a Form 483 with 2 observations to Mayo Clinic PET Radiochemistry Facility in Jacksonville, Florida (FEI 3014201471) after an inspection that ran Apr 9 – Apr 12, 2019. The investigator was Libia M. Lugo. The most-cited regulation is 21 CFR 212.30 (what requirements must my facilities and equipment meet?).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your facilities are not adequate to ensure the prevention of contamination of equipment or product by…
- 02
You did not document your activities in accordance with your procedures to ensure that all equipment…
This inspection in context
Libia M. Lugo
24 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmMayo Clinic PET Radiochemistry Facility history
The site's inspection history, in date order.
Similar 483sOther sites cited under 212.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mayo Clinic PET Radiochemistry Facility?
FDA listed 2 observations on this Form 483. The most-cited regulation is 21 CFR 212.30 (what requirements must my facilities and equipment meet?). The opening words of each observation are shown on this page.
Who inspected Mayo Clinic PET Radiochemistry Facility?
Libia M. Lugo is named on this Form 483, for the inspection of Apr 9 – Apr 12, 2019. Each investigator has a profile showing what they cite most.
When was Mayo Clinic PET Radiochemistry Facility inspected by FDA?
The inspection ran Apr 9 – Apr 12, 2019, and the Form 483 is dated April 12, 2019.
How do I get the full Form 483 for Mayo Clinic PET Radiochemistry Facility?
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.