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