Cambridge Isotope Laboratories, Inc. - Aug. 30, 2022
Issue Date
Aug 30, 2022
Region
Northeast
Category
Drug
$117.00
Contact Name
Joseph E. Mack
Contact Title
Senior QA Manager
Address 1
50 Frontage Rd.
City
Andover
State
MA
Zip/Postal Code
01810-5413
Inspection Range
Aug 15, 2022 - Aug 30, 2022
Pages
2
First Observation
The firm has failed to adequately investigate a failure for Loss on Drying (LOD) within the Accelerated Stability studies for Urea (C13, 99%) packaged in ... bottle in that the firm had not evaluated the potential impact between the failed accelerated stability study data and long-term stability data as well the container closure system but instead determined that the ... mL bottle was not suitable for accelerated stability studies.
Investigator(s): Robert J. Martin