Inspection Record
Inspectors Jeffrey D. Meng · Emily J. OrbanThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
The design of the A TNAA remediation process did not adequately evaluate all variables to consistently detect and remove all ATNAA units with atropine REDACTED (B)(4) and/or pralidoxime REDACTED (B)(4) REDACTED (B)(4)% of target).
'On 10/1/13, during FDA review of remediated pouches from 10 of REDACTED (B)(4) outer shipping boxes from ATNAA lot 2M1257, 3 pouches out of REDACTED (B)(4) were observed to be missing the "R" used to denote they had been remediated.
Written process validation protocols for the remediation of ATNAA units were not followed.
The ATNAA (Atropine 2.1mg/0.7mL and Pralidoxime Chloride 600mg/2.0mL Injection) auto-injector r emediation process was not validated to consistently detect and remove all ATNAA units with atropine REDACTED (B)(4).
The switching rules in the ISO-2859-1 standard, which require tightened inspection and discontinuance when the appropriate thresholds for failed lots are met, were not applied.
The ATNAA batch records are deficient in that they do not include identification of the persons performing each significant step in the operation.
Extracted automatically from the document US FDA published on 2024-01-17. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
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