Post-Inspection Acitvities

A formal response to all 483 items should be sent to the FDA district office within 10-15 days after completion of the inspection, even if this is not legally required. Issuing a formal response can help to reassure the agency of the company’s good intentions and thereby minimise the potential for further regulatory action. It is important that responses to individual 483 observations are not only product related but also system related.
Each observation should be accompanied by a detailed, scientifically justifiable plan with reasonable timelines for implementation and finalisation as a minimum requirement. Show evidence of implementation and do not make the mistake of writing general statements such as “We will fix this problem”, “This will not happen again next time”. These statements will not be accepted.

If missing documentation such as SOPs has been cited, it may be worthwhile writing, approving and implementing relevant SOPs and attaching authorised copies to the first response (a translation may be necessary).

In the April 2002 edition of the Gold Sheet, FDA inspector Kim Trautman recommends that it may occasionally be advisable to exceed the 15 day first-response period if you have been unable to compile, specify or scientifically formulate plans or corrective measures within this timeframe. A native speaker should review the final response. If you have missed the deadline for implementing corrective measures, you should inform the FDA and explain what has happened and what your new timeframe is.

The company can request that the 483 responses are filed together with the 483 report and that the responses are released along with the 483 report if access to the documentation is requested in line with freedom of information legislation.

The FDA inspector will write an EIR (establishment inspection report) that includes the 483 observations, further details on the site’s operations and additional GMP comments. This report is placed in the company’s file and is also available under freedom of information legislation. This is the main difference between the FDA and most other regulatory bodies, where inspections are considered confidential and are only discussed between the government and the company. It is vital for the company to have a copy of the FDA establishment inspection report, to read all of the inspector’s additional comments and concerns and to use this material for subsequent inspection preparations.

It is crucial that the progress of corrective measures is closely monitored. It is inevitable that there will be another inspection…