1Other quality system
Failure to validate a process for remediation of ATNAA (Atropine 2.1mg/0.7mL and Pralidoxime Chloride 600 mg/2 mL Injection) auto-injectors.
Inspection Record
Meridian Medical Technologies, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
You failed to follow the ISO 2859-1/ANSI/ASQ Zt.4 Standard.
3Quality unit oversight
The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
4Process validation
Written production and process control procedures are not followed in the execution of production and process control functions.
5Other quality system
You failed to collect your AQL Samples randomly.
6Other quality system
Failure to validate a process for remediation of ATNAA (Atropine 2.1mg/0.7mL and Pralidoxime Chloride 600 mg/2 mL Injection) auto-injectors .
7Validation and qualification
Insufficient qualification in the remediation of ATNAA (Atropine 2.1mg/0.7mL and Pralidoxime Chloride 600 mg/2 mL Injection) auto injectors.
About this record
Extracted automatically from the document US FDA published on 2025-06-20. 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.
