The firm’s explanation to FDA fit in one sentence: it did not know the requirement existed, because the tool never told it.
In this article
What the FDA letter says about the tool.
FDA issued Warning Letter 320-26-58 to Purolea Cosmetics Lab on April 2, 2026, after inspecting its Livonia, Michigan drug manufacturing facility from October 28 to 30, 2025. The letter cites a range of CGMP violations, including insanitary conditions, microbiological and component testing, and a quality unit that did not exercise its responsibilities. One section is headed “Inappropriate Use of Artificial Intelligence in Pharmaceutical Manufacturing.”
That section records that the firm told investigators it had used AI agents “to create drug product specifications, procedures, and master production or control records to be in compliance with FDA requirements.” FDA then states the expectation in plain terms:
“If you use AI as an aid in document creation, you must review the AI generated documents to ensure they were accurate and actually compliant with CGMP. Your failure to do so is a violation of 21 CFR 211.22(c).”FDA Warning Letter 320-26-58, April 2, 2026 · Read the letter on FDA.gov
The letter then gives the example. Investigators found that the firm had not conducted process validation before distributing its drug products, as 21 CFR 211.100 requires, and told the firm so. The firm replied that it was not aware of the legal requirement, because the tool it used “never told you it was required.”
FDA also states what it expects if the firm resumes production and uses a tool for CGMP activities such as developing procedures and specifications: any output or recommendations “must be reviewed and cleared by an authorized human representative of your firm’s QU.” The firm has since ceased drug production.
Two points follow from the text itself. The review is the quality unit’s responsibility, and the letter treats the tool’s output as something the quality unit must review and clear. And the failure FDA describes is not a wrong step. It is a requirement that never appeared.
A draft is silent where the risk is.
When a reviewer reads a drafted procedure, the natural question is whether each step is right. A fluent, well-organized draft invites that question, and a competent reviewer can answer it. Every step can be accurate and the review can still miss the point, because the missing requirement is not one of the steps.
That is why an omission is the hardest error to catch. There is nothing wrong on the page to notice. A reviewer who reads the draft against the draft will approve what it says and never see what it leaves out.
The same applies to a human author, but a human author usually owns the requirement set: the person who writes a validation procedure knows validation is required. A tool does not carry that obligation. The regulation requires the procedures to “include all requirements in this subpart” (21 CFR 211.100(a)), and the requirement set has to come from somewhere other than the draft.
The practical test: could the review have found a requirement the draft never mentions? It can only do so if the reviewer holds a list of the requirements that apply, written from the regulation and the site’s approved sources, before opening the draft. A list built from the draft only confirms the draft.
An illustrative scenario
The review, as performed, answered the question it was set: are these steps correct? It could not answer the question that mattered: is anything required that these steps never mention? Nothing in the file shows that anyone asked.
Had the reviewer started from a requirements list prepared before opening the draft, the missing item would have shown up as a gap, and the clearance would have named it, with an owner and a date, instead of passing over it. The difference is not the reviewer’s skill. It is where the review started.
What the clearance record should contain.
The Four Lenses keep the clearance from running ahead of the evidence. Each asks a different question of the same document. Applied to the illustrative scenario, a record that preserves the clearance decision might read as follows. This is a fictional example, not a template for a real decision.
| Lens | What the record contains | Question before clearing |
|---|---|---|
| EvidenceWhat was known? | The draft, the approved formulation and specifications it was compared with, and a requirements list written from the regulation and site procedures before the review began. | Against which independent sources was the draft checked? |
| JudgmentHow was the evidence evaluated? | Every step compared with its source. The requirements list shows one requirement the draft never mentions; its silence is recorded as a gap, not as proof that nothing was required. | Was the draft cleared on what it says, or on what it should have said? |
| RiskWhat remained uncertain? | The open requirement, what use of the document is held until it is closed, and any other document drafted with the same tool that needs the same review. | What remains open, who owns it, and by when? |
| AuthorizationWhat was decided? | A named quality unit representative clears the corrected document for use, for one revision, and records that any revision needs a new review. The clearance is not delegated to the tool or to the author of the draft. | Does the record show who held the authority and what they relied on? |
What the record should explain.
A drafted document that was used proves only that it was used. The record that answers an inspector shows who cleared it, against what, what the review found missing, and what was left open. If those answers are rebuilt from memory after the question is asked, they are reconstruction, not the original decision.
Make each clearance answer four questions.
- Who cleared it? Name the quality unit representative and the date, and confirm the clearance was not delegated to the author or the tool.
- Against what? List the approved sources and the requirements list, and show that the list was written before the review began.
- What did the review find missing? Record each gap, including requirements the draft never mentions, with an owner and a date.
- What triggers a new review? State that any revision, and any new document drafted with the same tool, needs its own clearance.
For the underlying question of whether a record can explain a decision without reconstruction, read could you explain this decision without reconstructing it?
Regulatory context and sources
For finished pharmaceuticals, 21 CFR 211.22(c) gives the quality control unit responsibility for approving or rejecting all procedures or specifications impacting the identity, strength, quality and purity of the drug product, and 211.22(a) gives it authority to review production records to assure that no errors have occurred or that any that did were fully investigated.
21 CFR 211.100(a) requires written production and process control procedures, including any changes, to be drafted, reviewed and approved by the appropriate organizational units and reviewed and approved by the quality control unit, and requires those procedures to include all requirements in the subpart.
Source context: FDA Warning Letter 320-26-58, Purolea Cosmetics Lab, April 2, 2026; 21 CFR 211.22, Responsibilities of quality control unit; 21 CFR 211.100, Written procedures; deviations. Quotations from the letter are verbatim; the firm’s identity and the redacted tool name are as published by FDA.