Preparing for FDA inspections and responding to Form 483 observations
Answering warning letters, untitled letters and FDA requests for records
Releasing detained shipments and petitioning for removal from import alerts
Running recalls and market withdrawals with FDA and customers
FDA Enforcement Defense: Inspections, Warning Letters, Import Alerts and Recalls
FDA enforcement usually starts with a deadline. An inspection ends with a Form 483, a warning letter asks for a written response within 15 working days, and a detention notice gives an importer a short window before product is refused. The first response shapes what comes next, including whether FDA escalates and what a plaintiff's lawyer can later use.
MDRXLaw represents manufacturers, importers, distributors, pharmacies and brand owners across FDA-regulated products. Because we are also a litigation firm, we draft every regulatory response with an eye on the lawsuits that can follow.
Inspections and Form 483s
Inspection readiness: mock reviews of records, complaint files and procedures, and training for the people who will speak with investigators.
During the inspection: guidance on document requests, photographs, affidavits and the close-out discussion.
Form 483 responses filed within 15 business days so FDA considers them before deciding whether to issue a warning letter, with corrective action plans that can actually be completed.
Warning Letters and Other Agency Action
Warning letter and untitled letter responses, including labeling, claims, cGMP and website or social media violations.
Regulatory meetings and close-out, including follow-up correspondence and requests for a close-out letter.
State coordination with state health departments, boards of pharmacy and attorneys general when the same issue draws their attention.
Detentions, Refusals and Import Alerts
We respond to Notices of FDA Action, present evidence to release product, propose relabeling or reconditioning where that is the faster path, and petition to remove products, manufacturers or shippers from import alerts. See also our pages on importing food and importing cosmetics.
Recalls and Market Withdrawals
Deciding whether a problem calls for a recall, a correction or a market withdrawal, and what classification to expect.
Recall strategy, notices to customers and distributors, effectiveness checks and FDA status reports.
Supplier, insurer and indemnity claims after the recall, and defense of related consumer suits.
Why MDRXLaw
A warning letter, a state inquiry and a consumer class action can arrive together. We handle the regulatory response and the litigation as one matter, so a statement made to FDA does not become an admission in court. Where a response needs testing or technical support, we retain qualified outside laboratories and consultants and manage their work.
Talk to Us
If FDA has inspected your facility, sent a warning letter, detained a shipment or asked you to recall a product, contact us promptly. The response deadlines are short.
