Mayo Clinic PET Radiochemistry Facility

FDA inspection history in Phoenix, Arizona, 2019

1
Form 483

Every document, by year

  • Form 483

2019: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2019One Form 483, at Phoenix, Arizona.

Cited most

Across all Mayo Clinic PET Radiochemistry Facility observations on file

  • 21 CFR 212.30(b)
    What requirements must my facilities and equipment meet?
    1
  • 21 CFR 212.50
    What production and process controls must I have?
    1
  • 21 CFR 212.60(c)
    What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?
    1

The complete Mayo Clinic PET Radiochemistry Facility file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2019-12-12483 Form 483$99

Investigators on these documents

Christopher M. Jenner (1)Zachary A. Bogorad (1)

FEI number 3012626823 · most recent document Dec 12, 2019

About Mayo Clinic PET Radiochemistry Facility

How many FDA Form 483s has Mayo Clinic PET Radiochemistry Facility received?

FDA Intel has 1 Form 483 on file for Mayo Clinic PET Radiochemistry Facility; the most recent is dated Dec 12, 2019.

When was Mayo Clinic PET Radiochemistry Facility last inspected by FDA?

The most recent FDA inspection document on file for Mayo Clinic PET Radiochemistry Facility is a Form 483 dated Dec 12, 2019, for the site in Phoenix, Arizona.

What did FDA cite at Mayo Clinic PET Radiochemistry Facility?

The regulations cited most in the observations on file for Mayo Clinic PET Radiochemistry Facility are 21 CFR 212.30(b) (What requirements must my facilities and equipment meet?), 1 time; 21 CFR 212.50 (What production and process controls must I have?), 1 time; 21 CFR 212.60(c) (What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?), 1 time.