FDA inspection completed by passing an interview and the interview, incidentally seals the fate expressed in the relevant company. In this final interview, FDA presents a written report on his mind, followed by a briefing. The report presented at the end of the interview is mainly prepared for internal use FDA and view the company is not allowed to see the report.
Exit interview must be made by an inspector host, Chancellor, and senior management of both quality and production. Others may apply if applicable.
As mentioned in the interview that the study provide a written report. It is expected for the organization, post-industrial niche, companies such as pharmaceutical ones are required to comply with Good Manufacturing Practice (cGMP) regulations and device user facilities must follow the Safe Medical Devices Act (SMDA, 1990) and Medical Device Reporting ( MDR) regulations.
If found not followed, a researcher at endpoint issues the report on the company mentioning GMP violations and regulatory discrepancies that it finds during the investigation. This report is commonly known as FDA Form 483 or “Notice of Inspectional Observation”. However, the form contains only observation related to violations of the rules and not any suggestion, recommendation, opinion of the inspector.
The norm organization, get 483 citations reviewed one-by-one. Investigators forward their views and opinions on each item. Management can specify the actions they intend to take to correct the situation or they may take exception to the investigator notes. Form 483 should contain only those observations that can be directly related to the violation of the rules, not suggestions, guidance or other comments investigated person. Although the 483 is not a reference to the rules, each study should be directly attributed to the part of the current regulations. Despite this norm, it is often found that the report contains ambiguities and personal bias on the part of supervisors and regulatory definition material can be interpreted differently.
Generally, take 483 references one of the below mentioned two forms:
“ GOTYAs ” – comments for minor documentary and mistakes
and Serious GMP fraction
It is obvious that each Form 483 contains issues that require immediate attention, yet the company staff will clarify any doubt of the investigator observation. Efa investigating party will also help clarify doubts and do better in the next inspection. If you need further clarification, you can also write a letter to the agency’s headquarters.
However, at the end of the interview, the inspector present a copy of the 483 to the company publicly and call an end to their investigation.
Action following 483
Version Form 483 should be followed by several steps that are not only important but essential in order to prevent the warning letter from the agency
Regardless of the comments made at the end of the interview letter must be written to the District Director mentioning the necessary steps to take in order to correct anomalies and the timetable for completing these improvements also need to be in the letter.
In order to increase the speed necessary corrective actions, encourage the formation of action groups is very necessary.
Advances in corrective actions should be monitored at a high level.
Once completed, a letter should be sent to the District Director to inform him of the call.
In the case of FDA believes GMP fraction serious, or if it wants to verify the implementation adjustments, it organizes follow-up inspection on site. Follow-up inspection at a convenient time for both parties promised improvements completed.
If the follow-up inspection FDA believes the corrective actions are not completed, it may take punitive measures as the confiscated goods, shutting down the facility and impose fines.