Northland Nuclear Medicine, LLC
5 extracted findings
FDA source excerpt, selected passage
Your firm failed to conduct adequate investigations and take appropriate corrective action when a failure of a production batch or any component of the batch failed to meet any of its specifications (21 CFR 212.20(d)).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
Your firm failed to conduct adequate investigations and take appropriate corrective action when a failure of a production batch or any component of the batch failed to meet any of its specifications (21 CFR 212.20(d)).
Source passage selected by the model
02
You failed to conduct adequate effectiveness checks for CAPAs to prevent recurrence.
Source passage selected by the model
03
You failed to adequately control your EM contact plates used to monitor your production operations.
Source passage selected by the model
04
Your firm failed to ensure adequate control of airflow in the ISO 5 critical aseptic processing area. Smoke studies conducted at your facility did not include a dynamic evaluation of LAFW or **(b)(4)** operations and therefore do not adequately demonstrate that unidirectional airflow effectively controls air quality during aseptic manufacturing.
Source passage selected by the model
05
You failed to adequately disinfect the exterior surfaces of the **(b)(4)** prior to aseptic manufacturing operations and failed to establish written procedures for the cleaning and disinfection of **(b)(4)** surfaces.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.