Phase 1
Inspection Readiness
1Maintain an inspection readiness program
A designated coordinator, a trained escort team, and a clear process for the first hour of any inspection.
Readiness practice
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2Keep records organized and retrievable
Records accurate, legible, created at the time of the activity, and retained at least 2 years at the facility.
21 CFR 117.305 · 117.315
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3Keep the food safety plan complete and signed
Plan with hazard analysis, controls, supply-chain program, and recall plan, signed and dated by the owner, operator, or agent.
21 CFR 117.126 · 117.310
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4Run mock inspections
Internal or third-party mock inspections that follow the investigator's path and test the team under pressure.
Readiness practice
Phase 2
Opening and Conduct
Can the requested record be produced now?
YES → Provide a copy and log it
NO → Log it and state when it will be delivered
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5Receive the investigator and the notice
Credentials verified, the inspection coordinator notified, and the Notice of Inspection, Form FDA 482, received.
FD&C Act 704(a)
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6Hold the opening meeting and escort the tour
Scope and expectations clarified, and the investigator escorted at all times with questions answered accurately.
Readiness practice
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7Respond to document requests
Records requested are logged, reviewed, copied, and provided promptly, with offsite records retrievable within 24 hours.
21 CFR 117.320 · 117.315
Phase 3
Closeout
8Debrief daily and track observations
The team meets each day to review what was asked, what was seen, and what may be cited, and to start fixing what can be fixed.
Readiness practice
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9Attend the closing meeting
Each observation on the Form FDA 483 is read and discussed with management, and clarifying questions are asked.
FD&C Act 704
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10Correct and document on the spot where possible
Corrections made during the inspection are documented, and evidence of them is kept for the response.
Readiness practice
Phase 4
Response and Follow-Up
11Respond to the Form FDA 483 in writing
A written response with a corrective action plan, usually within 15 business days so FDA can consider it before classification.
FDA 483 process
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12Follow through and update FDA
Corrective actions completed on the dates promised, with evidence, and progress updates sent where actions take longer.
FDA 483 process
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13Review the outcome and reanalyze
Classification and any further FDA action reviewed, and the food safety plan reanalyzed for gaps the inspection exposed.
21 CFR 117.170
Inspection Classifications (Overview)
NAI - No Action Indicated
No objectionable conditions or practices were found, or those found do not justify further regulatory action.
FDA classification
VAI - Voluntary Action Indicated
Objectionable conditions were found, but FDA does not expect to take regulatory action, and the firm is expected to correct voluntarily.
FDA classification
OAI - Official Action Indicated
Significant objectionable conditions were found and regulatory or administrative action may be recommended, such as a Warning Letter.
FDA classification
Records Request Handling (Overview)
Log every request
One person records what was asked, when, who handled it, and what was provided.
Review before releasing
The coordinator checks that the record is the right one and complete, and provides copies.
Keep a duplicate set
A copy of everything provided is kept so the facility knows exactly what FDA has seen.
Be accurate and prompt
Records are provided promptly, and if something cannot be found, the facility says so and says when it will follow up.
Key Inspection Outputs (Overview)
Inspection log
Requests, records provided, interviews, and areas visited, recorded as the inspection happens.
Copies of records provided
A duplicate set matching what FDA received.
Form FDA 483 and written response
The observations received and the facility's reply, with the corrective action plan.
Corrective action tracker
Each commitment, owner, date, and evidence of completion, until closed.