Compliance after the product launches
FDA regulatory compliance does not end with clearance, approval, or a first shipment. Device makers must run a quality management system, and the device quality rule has recently been realigned with an international standard, which changes some inspection expectations and terminology. Drug and supplement manufacturers follow good manufacturing practice rules, food facilities must have preventive controls in place, and cosmetics companies now face facility registration, product listing, and adverse event duties under a newer federal law. Across categories, companies typically must register facilities, keep certain records, and report certain safety events within set periods. The details depend heavily on the product type.
Complaints, events, and recalls
Complaint files are often the first thing an investigator asks to see. Each complaint should be logged, evaluated, and, where relevant, assessed for whether it is a reportable event, with the reasoning recorded. Trends matter, because repeated similar complaints can signal a problem that should have been investigated sooner. If a product may be defective or unsafe, recalls are usually conducted by the company in consultation with the agency, and the agency classifies them by risk. Keep supplier qualification records and change controls current, since a quiet change in a component or formula is a common source of findings.
Readiness rather than reaction
We look at whether your written procedures match what your staff actually does, because inspections often turn up gaps between the two rather than missing policies. A mock inspection or document review can surface problems while there is still time to correct them. We also review labeling, advertising, and social media claims, since marketing that drifts beyond what the product is cleared or permitted to claim is a frequent issue. If an inspection has already produced observations or a warning letter, the response timing becomes the priority, and we work from the specific findings outward. Corrective actions described in a response should be ones the company can actually complete and prove, because the agency may check them at the next visit.
