PETNET Solutions, Inc. - July 28, 2021
Issue Date
Jul 28, 2021
Region
Northeast
Category
Drug
$117.00
Contact Name
Michael Nazerias
Contact Title
Vice President, Regulatory Affairs & Quality Assurance
Address 1
350 Washington St.
Address 2
Unit 268
City
Woburn
State
MA
Zip/Postal Code
01801
Country
United States
Inspection Range
Jul 19, 2021 - Jul 28, 2021
Pages
2
First Observation
You did not implement procedures to ensure that all equipment is cleaned and suitable for its intended purposes that could reasonably be expected to adversely affect the identity, strength, quality, or purity of a PET drug, or given erroneous or invalid test results when improperly used or maintained.
Investigator(s): Samir C. Gala and Sean R. Marcsisin