FDA Inspections of Food Plants – Part 3 Post-Inspectional Strategy and Recommendations for Successful Inspection Outcomes

 and impressions, but will also identify improvement
Post-Inspectionand training opportunities. If the requested copy is
 not received within another 30 days, a call to the
At the conclusion of the inspection, the investigatordistrict office is warranted. A delay in receiving the
will request a closing meeting with management. IfEIR could be due to something as simple as a backlog
conditions that the investigator believes to be CGMPin the office, or, more ominously, a concern with the
deviations have been observed, a form FDA 483company's response to the FDA 483 and a potential
"Notice of Inspectional Observations" will be issued. Ifwarning letter. In the latter case, it is important to
any of the deviations have been corrected and thekeep the lines of communication open -- not as a
corrections shown to the investigator during thedelaying tactic but as a means of gaining an
course of the inspection, the investigator should beopportunity to correct a problem before it escalates
requested to annotate the FDA 483. (Note: Theany further.
investigator will not annotate the FDA 483 without 
being requested to do so. Only in the case of medicalRecommendations
device inspections is s/he required to comply with the 
request. In the writer's experience, investigators areThe FDA's food inspection system is overwhelmed,
usually willing to accommodate reasonable requests.)and the FDA's practice of depending on the states to
If there is disagreement with any of thefill the vacuum is a failure, as is the practice of food
observations, the basis for the disagreement shouldcompanies using private inspection services. If in
be noted for the record and the investigatordoubt, one need only compare the sterling plant
requested to include the company’s position ininspection reports of the Peanut Corporation of
the "Establishment Inspection Report" (EIR).America's Georgia and Texas plants issued by the
 states of Georgia and Texas and by the American
If the inspection results in a form FD 483 beingInstitute of Baking with the tragic results caused by
issued, it should be responded to in writing within 10products from those plants ( Although the FDA
days to assure that the company's position isencourages and has issued guidelines for third party
available to the investigator's supervisor when thecertification programs ( it is incumbent on each
EIR is reviewed. The response should describe incompany to develop its own systems to protect its
detail the actions that will be taken to correct thecustomers and shareholders. The following are
CGMP deviations and the time frame in which thenecessary steps:
corrections will be made. If a deviation is such that 
the corrective action will be prolonged, the response 
should provide a corrective action plan justifying the1. Develop an internal audit system owned, staffed,
schedule and explain what added controls will be inand operated by your own trained employees from
place until the deviation is fully corrected. If the FDplant manager to operator.
483 response is not timely or is unsatisfactory, then2. If you are a food manufacturer, develop a supplier
the company is on a trajectory to a Warning Letterquality management system -- again, owned, staffed,
and/or other enforcement actions.and operated by your own trained employees.
 3. Whether you are a supplier or manufacturer,
The company should request an unexpurgated copyconsider registering to the Food Safety Management
of the EIR from the FDA district office within 30Systems standard ISO 22000:2005. ( If properly
days of the conclusion of the inspection (whether orimplemented, this will raise the level of organizational
not a FDA 483 was issued). The EIR will not onlydiscipline and provide independent and unbiased
provide insight into the investigator's observationsassessments at specified intervals.