The FDA inspection ends with an exit interview and this interview seals the fate of the inspected company. In this exit interview, the FDA presents a written report of its inspection, followed by a debriefing. The report presented during the discharge interview is primarily prepared for internal FDA use and the inspected company is still not authorized to view the report.
Exit maintenance should be attended by the inspection host, scribe, and senior quality and manufacturing management. Others can attend if needed.
As mentioned earlier, during the interview, investigators issue a written report. The agency expects that depending on the industry niche, companies such as pharmaceutical companies will be required to comply with Good Manufacturing Practices (CGMP) regulations and device user facilities must Comply with the Medical Device Safety Act (SMDA; 1990) and Device Reporting Regulations (MDR).
If it turns out not to be followed, the investigator at the end of the investigation issues the report against the company mentioning the GMP violation and deviations regulations that he finds during the investigation. This report is commonly referred to as FDA Form 483 or "Notice of Inspection Observation". However, the form contains only observations relating to regulatory violations and no suggestions, recommendations, opinions of the inspector.
As the agency standard, all 483 citations are reviewed one by one. Investigators express their views and opinions on each item. Management can indicate the steps they intend to take to correct the situation or they can object to the investigator's comments. The 483 form should only contain observations that can be directly related to a regulatory violation, and not suggestions, advice or other comments from the investigator. Although 483 does not contain references to regulations, each observation must be directly linked to a section of the applicable regulations. Despite this standard, the report is often found to contain ambiguities and personal biases on the part of inspectors, as the regulations and the definition of significant may be interpreted differently.
Typically, the 483 quotes take one of the two forms mentioned below:
"GOTYAs"- comments regarding minor documentary and procedural errors
and, Serious violation of GMP
Obviously every Form 483 contains issues that require immediate attention, but company staff need to clarify their doubts about the investigator's observation. Interviewing the investigator will also help clarify doubts and do better on the next inspection. In case you need more details, you can also write a letter to the agency headquarters.
However, at the end of the interview, the inspector officially presents a copy of 483 to the company and ends their investigation.
Actions following 483
Show of Form 483 must be followed by a few steps which are not only important but necessary to avoid the agency warning letter:
Regardless of the comments made during the discharge interview, a letter should be written to the district manager stating the necessary actions to be taken to correct the deviations and the time frame for carrying out these corrective actions should also be mentioned in the letter.
In order to accelerate the pace of the corrective actions required, rapid formation of action groups is essential.
The progress of corrective actions should be monitored at a high level.
Once completed, a letter should be sent to the District Manager advising them of the success of the operation.
In the event that the FDA considers the GMP violations to be serious, or if it wishes to verify the implemented corrections, it arranges a follow-up site inspection. The follow-up inspection takes place at a time convenient for both parties after the promised completion of the corrective action.
If, during the follow-up inspection, the FDA finds that the corrective actions are not complete, it may take punitive actions such as forfeiture of the product, shutdown of the facility, and the shutdown. fine.