Mayo Clinic PET Radiochemistry Facility
Form 483 issued December 12, 2019 · Phoenix, Arizona
- Inspection
- Dec 10 – Dec 12, 2019
- Investigators
- Christopher M. Jenner· Zachary A. Bogorad
- Observations
- 3
- Pages
- 4
- FEI number
- 3012626823
In short: On December 12, 2019, FDA issued a Form 483 with 3 observations to Mayo Clinic PET Radiochemistry Facility in Phoenix, Arizona (FEI 3012626823) after an inspection that ran Dec 10 – Dec 12, 2019. The investigators were Christopher M. Jenner and Zachary A. Bogorad.
What FDA observed
Preview: the opening words of each observation- 01
Your firm lacks adequate production and process controls to ensure the consistent production of a PET…
- 02
Your laboratory analytical methods are not suitable…
- 03
You did not implement procedures and document your activities in accordance with your procedures to ensure…
This inspection in context
Christopher M. Jenner
11 documents · 2017–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Arizona.
The firmMayo Clinic PET Radiochemistry Facility history
The site's inspection history, in date order.
Similar 483sOther sites cited under 212.50
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 3 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Mayo Clinic PET Radiochemistry Facility?
Christopher M. Jenner and Zachary A. Bogorad are named on this Form 483, for the inspection of Dec 10 – Dec 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 Dec 10 – Dec 12, 2019, and the Form 483 is dated December 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.