FDA Inspection Reference · 21 CFR 211.100

FDA 483 — Deviation Continuation Authorization

FDA 483 Observation

"The firm failed to document adequate justification for the decision to continue manufacturing operations during an open deviation investigation."

The deviation report was complete.

The authorization record did not exist.

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If your inspection is within 90 days, this record either exists now or it does not.

If this record does not exist today, it will not exist at inspection.

The Question FDA Investigators Ask That Deviation Reports Cannot Answer

An FDA investigator reviewing a deviation file will ask two distinct questions.

The first is about the investigation. Root cause, corrective actions, effectiveness. The deviation report answers that. It was designed to.

The second is about the decision that preceded the investigation. Who authorized continuation. What evidence was reviewed at the moment that call was made. What regulatory standard authorized it under these specific circumstances.

The deviation report does not answer that question. It begins when the investigation begins. The continuation decision that made the investigation necessary produces no entry in the report. That gap is where 483 observations under 21 CFR 211.100 are written.

FDA Deviation Continuation — What Investigators Actually Require

FDA 483 deviation example Occurs when continuation decisions lack documented authorization — not when investigations are deficient.

Deviation continuation requirements 21 CFR 211 Require documented justification at the time of the decision — not reconstructed from the investigation report after the fact.

Can manufacturing continue during a deviation FDA Yes, but requires a formal authorization record created at the moment of the decision — named decision-maker, evidence reviewed, regulatory basis.

FDA deviation investigation vs continuation decision Two separate records. Most systems produce only one. The investigation report documents what followed. The authorization record documents who made the call and why.

FDA deviation investigation requirements The investigation record is required. The authorization record for decisions made during the deviation event is a separate and distinct requirement investigators ask for by name.

What the Observation Is Actually Citing

The deviation report will be thorough. Root cause documented. Corrective actions closed. Effectiveness verified. File approved. The observation is not about any of that.

It is written against what does not exist in the file: a formal record showing who made the continuation call, what they reviewed at the time, and what regulatory standard authorized continuation while the investigation was still open.

Under 21 CFR 211.100, deviations from written procedures require documentation and justification. The authorization record for the continuation decision is not a workflow output — it does not exist unless it is created deliberately, at the time of the decision, by the accountable decision-maker.

What a Defensible Authorization Record Contains

Named Decision-Maker Not who approved the deviation file. Who made the continuation call — by name and role — at the time the decision was made.
Evidence Reviewed at the Moment of Decision Not what the investigation later found. What was known and reviewed at the specific time the continuation decision was made.
Regulatory Basis for Authorization The specific CFR provision or internal procedure that authorized continuation under these circumstances. Not implied — explicitly stated.
Risk Assessment at Time of Decision The documented evaluation of product impact, patient safety, and regulatory risk performed before continuation was authorized.
Authorization Rationale The explicit reasoning connecting the evidence to the conclusion — why continuation was defensible at that moment, created in real time.

This is the record investigators ask for — not the deviation report.

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Why QMS Systems Don't Produce This Record

Quality management systems track workflow completion. They record that the deviation was opened, the investigation was conducted, the corrective actions closed, and the file approved.

They are not designed to capture the authorization logic behind real-time decisions made during active quality events. The continuation authorization record requires a deliberate act — created by the accountable decision-maker at the moment of the decision, in a form built to withstand direct investigator scrutiny.

Most deviation files don't have one. Not because the work was deficient. Because the system was never designed to produce it.

The Reconstruction Problem

Reconstruction is not a formal authorization record.

When a QA Director walks an investigator through the continuation reasoning — describing who was involved, what was reviewed, why the call was made — they are reconstructing a decision from memory. That reconstruction may be accurate in every detail. The reasoning may have been fully defensible.

But it does not have a timestamp from the moment the decision was made. It was not created at the time. Investigators know the difference. The observation is not about whether the decision was right. It is about whether the authorization was documented.

If Your Inspection Is Within 90 Days

The authorization records behind your deviation continuation decisions either exist now or they do not. A document created after an investigator asks the question is a reconstruction — not an authorization record.

The deviation report will hold. The question that follows is about the hours before the investigation began. That record has to exist before the inspection starts.

Produce the Deviation Continuation Authorization Record — $149

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FDA Deviation Continuation — Frequently Asked Questions

What is an FDA 483 for deviation?

An FDA 483 for deviation typically cites the absence of a formal authorization record for decisions made during the deviation event — not a deficient investigation. The most common observation: no documented justification for who authorized continuation, on what evidence, under what regulatory standard.

Can you continue manufacturing during a deviation FDA?

Yes, but the continuation decision must be formally authorized and documented at the time it is made. The authorization record must identify the decision-maker, the evidence reviewed, the regulatory basis, and the risk assessment. It must be created contemporaneously — not reconstructed after the fact.

What does 21 CFR 211.100 require for deviations?

21 CFR 211.100 requires that deviations from written procedures be documented and justified. For continuation decisions, this means a formal authorization record exists at the time the decision is made — not a reconstruction from memory. The deviation investigation report that follows does not satisfy this requirement.

What documentation is required during a deviation?

Two separate records are required: the deviation investigation report and the authorization record for decisions made during the deviation event. Most QMS systems produce the first. The second must be created deliberately — by the accountable decision-maker, at the time of the decision.

What is the difference between a deviation investigation report and a deviation authorization record?

The investigation report documents what happened after the deviation was identified. The authorization record documents the decision made at the time — who authorized continuation, on what evidence, under which standard, and why. The investigation report begins when the investigation begins. The authorization record must exist at the moment the continuation decision is made.