FDA inspection ends with an exit interview and that interview, incidentally seals the fate of the inspected company. In this exit interview, FDA presents a written report of its inspection, followed by a debriefing. Report presented in the exit interview is mainly prepared for the internal use of FDA and the inspected company remains non-permitted to see the report.
The exit interview should be attended by the inspection host, scribe, and senior management from both Quality and Manufacturing. Others may attend if appropriate.
As mentioned earlier, during the interview the investigators issue a written report. It is expected by the agency that, depending upon the industrial niche, companies such as pharmaceutical ones are required to comply with Good Manufacturing Practice (CGMP) regulations and device user facilities need to follow the Safe Medical Devices Act (SMDA; 1990) and Medical Device Reporting (MDR) regulations.
If found not complied with, the investigator at the end of investigation issue the report against the company mentioning the GMP violation 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 only contains observation related to violations of regulations and not any suggestion, recommendations, opinions of the inspector.
As a norm of the agency, the 483 citations get reviewed one-by-one. The investigators state their views and opinions on each item. Management may state actions they intend to take to correct the situation or they may take exception to the investigator comments. Form 483 should contain only those observations that can be directly linked to a violation of regulations-not suggestions, guidance, or other comments of the investigating person. Although the 483 does not contain references to the regulations, each observation should be directly traceable to a section of the applicable regulations. Despite this norm, it is often found that the report contains ambiguity and personal bias on the part of inspectors, as regulations and the definition of significant may be interpreted differently.
In general, the 483 citations take one of the below mentioned two forms:
“GOTYAs” – comments regarding minor documentary and procedural errors
and, Serious GMP violation
It is obvious that, every Form 483 contains issues requiring immediate attention, yet the company personnel must clarify their doubt over the investigator observation. Questioning the the investigating person will also help clarify the doubts and do better in next inspection. In case you clarifications need a more detail, you may also write letter to the agency headquarters.
However, at the end of the interview, inspector present a copy of the 483 to the company officially and call an end to their investigation.
Actions Following the 483
Issuance of Form 483 should be followed by a few steps which are not only important but indispensable in order to avoid warning letter from the agency:
Regardless of the comments made during the exit interview, a letter has to be written to the District Director mentioning the necessary steps to be taken in order to correct the deviations and the timetable for completing these corrective actions also has to be mentioned in the letter.
In order to augment the pace of required corrective actions, a prompt formation of action groups is highly required.
Progress on the corrective actions should be monitored at a high level.
When completed, a letter should be sent to the District Director informing him of the successful completion.
In case, the FDA considers the GMP violations as severe, or if it wants to verify the implemented corrections, it organizes a follow-up inspection of the site. The follow-up inspection takes place at a suitable time of both the parties after promised completion of corrective action.
If during the follow-up inspection FDA finds the corrective actions are not complete, it can take punitive actions such as confiscate products, shutting down facility and imposing fines.