Part 01 · The Question→Part 02 · The Record→Part 03 · The File
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Inspection Case File · CF10 · Part 02 of 03

The five fields the FDA investigator expects to find — and the one most files don't have.

A deviation closure with a signature is not the same as a deviation closure with a documented decision. The investigator can tell the difference in thirty seconds.

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What separates a decision from a signature

A signature on a CAPA closure form proves that a person signed. It does not prove what they decided.

Under inspection, a signature is evidence of an event. It is not evidence of a decision. The investigator does not doubt the signature. She doubts that anything was decided.

An authorization record is structured to be evidence of a decision. It names the person, the moment, the evidence reviewed, the alternatives evaluated, and the basis on which the conclusion was reached. The investigator does not have to ask the QA Director what she was thinking. The record answers.

Investigator
"Who authorized the conclusion that the complaint did not require regulatory reporting or product action, on what evidence, and how was that determination justified at the moment of decision?"
This is the question that requires Field 03 of the authorization record to exist.
The Authorization Record · Required Structure

Five fields. Missing any one is the gap a 483 cites.

Every authorization record for a deviation root cause conclusion must contain the following five fields. The third field is the one that is almost always missing.

  1. 01
    The determination being authorized
    Stated as a decision, not a description. Not "no further action." Specifically: the conclusion that the appearance variation reported in COMP-2024-0312 is cosmetic only and does not indicate a manufacturing, formulation, or packaging issue requiring further action, on the basis of retain examination, evaluation of adjacent lots in the campaign, complaint trend analysis, and risk evaluation supporting acceptance of residual patient safety risk.
  2. 02
    The investigation evidence reviewed at authorization
    Retain sample examination report. Adjacent lot review. Manufacturing campaign records. Complaint trend analysis for the product. Patient safety evaluation including consideration of vulnerable populations. Each item identified.
  3. 03
    Alternative dispositions evaluated and rejectedMost Often Missing
    The candidate dispositions considered before no-action was concluded. Not "we considered alternatives." The actual alternatives — extended testing on the affected lot, evaluation of adjacent lots, recall of the affected lot, field corrective action — and the documented basis on which each was rejected. This is the section a 483 cites when it is missing.
  4. 04
    The risk evaluation applied
    What was at stake if the no-action determination was wrong. Patient safety implications, product performance impact, regulatory reporting implications.
  5. 05
    The named decision owner and timestamp
    The individual whose authority basis is documented. Not the Complaint Investigator signature. The person who reviewed the investigation evidence, evaluated alternative dispositions, applied the risk standard, and authorized the no-action determination.
Why Field 03 matters most

A deviation file almost never contains a documented alternative-causes evaluation. The investigator opens to it first.

Most deviation investigations conclude with a single root cause. They rarely document the alternatives that were evaluated and eliminated to arrive there. The investigator knows this. It is the field she opens to first.

If field 03 is empty, every other field is suspect. The evidence in field 02 may have been reviewed, but no alternative interpretations are on record. The conclusion in field 01 may be correct, but the reasoning is unreconstructable. The signature in field 05 attests to the conclusion, not to the analysis that produced it.

An authorization record without a documented alternative-causes evaluation is not an authorization record. It is a signature on a conclusion.

Why this matters now

The five-field structure is the same whether the inspection is this quarter or next year. The difference is whether you build the record now — when you have time, evidence, and the original decision-maker available — or under inspection pressure when none of those are guaranteed.

Reference Example

DDR-COMP-001 — Losartan Potassium Tablets 50 mg — Complaint COMP-2024-0312

The same scenario from Part 01, with the authorization record that should have existed in the file. Excerpt from the complete reference DDR.

Decision Defense Record · DDR-COMP-001 · Excerpt
Complaint Investigation Disposition — COMP-2024-0312
Decision Authorized
The conclusion that the appearance variation reported in COMP-2024-0312 for Losartan Potassium Tablets 50 mg, Lot 2024-0623 represents cosmetic variation only, does not indicate a manufacturing, formulation, or packaging issue, and does not require further action — on the basis of retain examination, adjacent lot review, complaint trend analysis, and patient safety evaluation.
Authorizing Individual
Dr. James Whitman, VP Post-Market Quality
Authority Basis
COMP-AUTH-002 §3.4 — designated authority for complaint disposition authorization on cardiovascular products
Evidence Reviewed
COMP-2024-0312 · Retain examination RX-Lot-2024-0623 · Adjacent lot review (2024-0621, 2024-0622, 2024-0624) · Manufacturing campaign records MCR-Losartan-Q2-2024 · Complaint trend analysis CTA-Losartan-2023-2024 · Patient safety evaluation PSE-COMP-0312
Alternatives Eliminated
Extended physical and chemical testing on affected lot · Evaluation of adjacent lots · Voluntary recall of affected lot · Field corrective action notification · Regulatory reporting trigger evaluation — each evaluated against documented evidence
Authorization Timestamp
July 15, 2024 — 14:22 EST
Regulatory Framework
21 CFR 211.198 · 21 CFR 211.192 · ICH Q10 · 21 CFR 803 (where applicable)
— Continued in the complete file —
Inspection Exposure Snapshot

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Continued · Part 03 of 03

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