1. FDA 483 ObservationsResolving the IssuesCompliance Insight, Inc. 513-860-3512 Copyrighted 2013

2. What to do now?If you are reading this now, you are probably in the middle ofsome sort of FDA enforcement issue. Responding to FDA 483observations can be one of the most important, and mostchallenging, activities in your career and the companyshistory.Failure to ensure a proper response and failing to clearlyindicate to the FDA that you are in CONTROL can be fatal toyour business.

3. Writing the Response 14 PointsThere are some basic rules that can beestablished regarding writing a responseletter.Some or all of these rules may applydepending upon the particular situation ofthe firm e.g. lengthy list of observationsfrom a governmental body, client audit,warning letter pending, etc.

4. 14 Points to Success1. Someone in a high level in the Quality Department shouldwrite the response.2. Personnel copied on the response should include high-level management. This shows that management at thefirm is aware of the issues and the commitments beingmade.3. Include a cover letter or opening statement. Thank theauditor(s) for being professional, providing insight orother appropriate remarks as warranted. State the siteaddress of the audit and the dates.4. Always remember that you are writing the response tothe auditors management governmental auditingbodies as well as clients. Do not assume that the personreading the report understands the context of theobservation or your reply.

5. 14 Points to Success5. Re-state the observation and reference number in theresponse. Typically, the observation goes directly abovethe response.6. If possible, indicate the related compliant systems. Thisshows that you are in control and that some operationswere functioning within acceptable GMP parameters.7. If the action item is going to take some time toimplement, state what will be done in the interim to becompliant with GMPs? Dont simply indicate that actionswill be taken in six months to correct the issue in whichyou are currently out of compliance without addressingwhat you will do to be compliant from the current dateuntil the corrections are implemented.

6. 14 Points to Success8. If corrective actions have already taken place, indicate thefollowing: Dates implemented Training performed (copies of training sign-upsheets included) Copies of Purchase Orders, installation work,etc. Copies of updated SOPs indicating what waschanged.9. Define how enhancements will prevent recurrence of theissue observed. Dont assume that the reader willunderstand this fact.10. Explain what will be done to expand, enhance orstreamline the compliance system.

7. 14 Points to Success11. Dont forget about training. Allow sufficient time toimplement changes to incorporate training that mayinclude proficiency testing.12. Describe how the firm will monitor the progress andeffectiveness of the corrective actions.13. It may be helpful to explain that despite the issues noted,there has never been an issue. It is not advisable to usethis response tactic each time but it can be advantageousfor critical observations to state something on the orderof the product has always met predetermined qualityparameters14. Revise, revise, revise. Allow other people not directlyinvolved with the audit to review and comment on theresponse. They may have insight on response wordingthat would assist in clarification or strengthening ofpoints.

8. 7 Actions to AvoidAlthough the following information is not an exhaustive list,there are some strategies taken by firms that indicate to anauditor the firms unwillingness to change or inability to makeappropriate corrective actions.If a firm does not have the capability, time or experience torespond appropriately to an audit (especially a governmentaudit), a prime directive should be to seek outside assistance.AVOID At all costs!

9. Pathway to Disaster1. During the closeout or in the response letter, argue everypoint in that they are not appropriate or we havenever had an issue with this point from other auditors.This is called a scorched earth policy and will ensurethat the auditor has a strong message of non-complianceto the auditor body.2. State that the corrective actions being requested will putthe firm out of business or drive jobs to a foreigncountry. It is a scare tactic that has been used for atleast 20 years and has not proven to be the case.3. The rain forest or overwhelming response. Includemassive amounts of data that is not warranted with thehopes that the reviewer will be impressed with thework. This type of response sends an immediate warningsignal to the auditor that issues are being glossed over.

10. Pathway to Disaster4. Implement changes immediately. Either duringthe closeout meeting or with a quick response,all changes have been implemented for complexissues. If the issue is simple, great noproblem. However, for complex observations, arapid response indicates that the firm has takena knee-jerk reaction and implementedcorrective actions without thinking of the rootcause.5. Not responding to the audit. Actions may betaken but no formal letter is sent indicatingwhat was performed. This approach indicatesthat the firm does not take the audit seriously.

11. Pathway to Disaster6. The enigmatic response. The firm indicates thatactions are going to be taken but does notaddress what these actions include. Such anexample would include: Actions Taken Records were updated. When? How were theyupdated?7. Promise without substance. Similar to theenigmatic response, this approach does notindicate any specifics. An example includes:Deficiency Detailed investigation notperformed in a timely manner. Response Investigations will be carried out in a timelymanner.

12. Assess SystemicallyResolve Issues or Plan to Resolve Systemically, across all sitesFinish the Response If serious enough,follow-up with your district officeVerify that the resolutions workedThe FDA 483 Phases to ResolvePhase 4Phase 1Phase 2Phase 3

13. The Choice is Yours!Work diligently now or face serious issuesin the future

14. Questions? More Information?Compliance Insight, Inc.www.Compliance-Insight.com513-860-3512FDA483Team@Compliance-Insight.comWe have a significant source of information to help you ondealing FDA 483s Contact us for a free consultation.