StimLabs, the Roswell-based regenerative medicine company, passed a federal inspection Aug. 6 without any corrective action required, the best possible outcome for a medical device manufacturer under FDA scrutiny.

The U.S. Food and Drug Administration inspected StimLabs' facility at 1225 Northmeadow Parkway, Suite 104, according to North Fulton Today, which reviewed FDA inspection data. The review covered two areas: device compliance and postmarket assurance for devices.

The result means FDA inspectors found no objectionable conditions or practices at the facility. Under the agency's classification system, that outcome is labeled "No Action Indicated," the cleanest of three possible grades. The other two, "Voluntary Action Indicated" and "Official Action Indicated," flag problems of increasing severity, with the latter triggering recommended regulatory action.

StimLabs, founded in 2015 by CEO John Daniel, employs between 201 and 500 people according to its LinkedIn profile. The company specializes in wound care and surgical products, including human placental membrane grafts and umbilical cord-derived devices. It has secured multiple regulatory milestones in the past year: ISO 13485:2016 certification in September 2025, FDA 510(k) clearance for Theracor in December 2025 and clearance for DermaForm, a collagen scaffold wound care device, in February 2026.

"After 10 years, StimLabs continues to focus on innovating technologies and driving advancements that redefine standards and progress in healthcare," Daniel said in a Dec. 29, 2025, press release announcing the Theracor clearance.

The company also landed a national contract with Vizient in August 2025, giving its products access to more than 3,500 U.S. hospitals, including 97% of academic medical centers.

Chief quality and regulatory officer Melissa O'Connor oversees StimLabs' compliance operations. The company did not provide comment on the Aug. 6 inspection.

The FDA typically sends a final classification letter within 45 to 90 days of an inspection's close, which would place StimLabs' formal letter sometime between late September and early November.