Just inspected by FDA? A structured 30-day engagement that delivers your formal written response on or before the 15-business-day deadline — drafted to FDA expectations, with a CAPA plan against every cited observation, and a senior QA engineer (ISO 13485 / 21 CFR Part 820 lead) leading the work.
If you've just been inspected by FDA and the response deadline is staring at you, this engagement is structured for exactly that situation.
Recently received a Form 483 with observations. Need a written response submitted to FDA within the standard 15-business-day window.
Issued a Warning Letter and need a formal response strategy backed by senior QA judgment. Higher-stakes than a 483; same response framework.
10–200 employee device firms whose Quality VP just left, was let go pre-inspection, or never existed. No internal capacity to draft a defensible response.
Cited under 21 CFR 211.22(c) for AI-generated SOPs, specs, CAPAs, or production records that bypassed Quality Unit review. Response scoped to the Purolea (320-26-58) standard.
On April 2, 2026, FDA issued Warning Letter 320-26-58 to Purolea Cosmetics Lab — the first cGMP enforcement action explicitly citing AI overreliance as a distinct, named violation. FDA invoked 21 CFR 211.22(c) against AI-generated drug specs, SOPs, and master production and control records that entered the QMS without Quality Unit review. Every regulated firm using AI in GxP documentation now operates under that template.
FDA's verbatim remediation standard: "Any output or recommendations from an AI agent must be reviewed and cleared by an authorized human representative of your firm's QU in accordance with section 501(a)(2)(B) of the FD&C Act." If your inspection touched AI-assisted SOPs, CAPAs, validation protocols, design controls, supplier responses, or production records, the response must demonstrate that the QU oversight gap is closed — not just promised.
This 30-day response engagement covers the fact pattern directly: retroactive QU-review evidence assessment across AI-touched documents, SOP for authorized-reviewer-by-document-type, audit-trail design that survives an investigator's request, and a remediation roadmap that maps to the verbatim FDA standard above. The engineer signing the response is the same person reviewing the work — no AI substitution in the deliverable that defends you against AI substitution.
📧 Inquire About AI-Overreliance ResponseEngagement scoped to land your formal response on or before the 15-business-day FDA deadline, with remediation continuing through day 30 and beyond if retainer is engaged.
Review the 483 / Warning Letter findings within 48 hours of engagement. Identify scope, severity, and any observations that require immediate action.
Build the CAPA (Corrective and Preventive Action) plan covering every cited observation. Draft the formal written response in standard FDA format.
One mock-audit / readback session before submission. Pressure-test the response with someone who's been on the inspector's side. Adjust before submission.
Final response submitted on or before the FDA deadline (15 business days from 483 issue date, or as specified on Warning Letter). Implementation roadmap with deadlines included.
The 30-day response package is the primary engagement. The monthly retainer continues remediation oversight and prepares you for follow-up inspection.
Honest scope. If your situation requires one of these, I'll refer you to qualified specialists.
Initial intake within 24 hours of inquiry. The 30-day timeline begins on engagement start date — typically same-day or next-day after first call. If your 15-business-day deadline is already underway, we adjust the timeline to fit what's left.
Compressed-timeline engagements are accommodated. Rate may adjust for expedited turnaround. If the deadline is less than 5 business days away, I'll tell you on the first call whether a quality response is achievable in the remaining time.
Yes. FDA cares about the substance and credibility of the response, not who drafted it. The response is submitted on your firm's letterhead, signed by your responsible person. My role is engineering judgment and document drafting — your firm owns the submission.
Yes. A mutual NDA can be executed before any 483 / Warning Letter content is shared. Standard one-page template available; custom NDAs accommodated.
If the optional monthly retainer is engaged, I provide pre-inspection mock audits and am available by phone during the follow-up inspection. If the retainer is not engaged, follow-up inspection support is scoped separately.
If the Warning Letter or 483 involves consent decree exposure, parallel litigation, recall execution, or 510(k) issues, I'll tell you on the first call which parts of the response I can own and which require specialized counsel. The 30-day package is for standard 483 / Warning Letter responses; complex situations are scoped separately.
If your 15-business-day deadline is running, every day matters. Email for fastest intake — response within 24 hours, engagement start same- or next-day. Calendar booking available for non-urgent intake.