There are 3 observations under Form 483 and management has advised that they are minor in nature.
As per my understanding the Auditors post inspection will now EIR (Establishment Inspection Report). The report along with other things will have observations under 483. This report will be reviewed by US FDA authorities and based on it action will be classified.
The FDA inspections may be classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI)** in the increasing severity order depending on the outcome. When no Form FDA 483 (Inspectional Observations’) is issued, the inspection is classified as NAI.
When a Form FDA 483 is issued, it may be classified as VAI or OAI depending on the significance and severity of the deficiencies.
An FDA 483 observation is a notice that highlights potential regulatory problems, while a warning letter is an escalation of this notice . You need to respond in writing within 15 days of receiving both a 483 and a warning letter.
OAI classifications may lead to further regulatory actions including Regulatory Meetings, Untitled Letters, Warning Letters, Import Alerts, Injunctions and Seizures. Irrespective of the classification, each inspection will have an Establishment Inspection Report (EIR) written by the FDA investigator and a copy will be sent to the firm as per FMD-145 (Field Management Directive). The investigators are also expected to report significant discussions with the firm management in the EIR.
A Warning Letter constitutes official but not final, agency action.(Observations will be classified Official Action Indicated), OAI, whenever a Warning Letter is issued** . This procedure provides greater consistency and uniformity in the classification system and regulatory policy.
As the managment has claimed that the observations are minor in nature and also depending on the corrective actions and reply submitted by the Company, it is likely that the classification by the FDA should be VAI and not OAI.
I would request any Pharma expert to advise the implication and way forward.
(How much time it takes for coming out of VAI and what is the impact on revenue and operations from the unit where VAI has been initiated)
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