Mesa Labs reports Q2 revenue of $62.3m and says FDA inspection of Bozeman plant found no issues
The US sterilisation-assurance supplier issued its first fiscal 2027 guidance and said a September FDA inspection of its Montana biological indicator site closed without Form 483 observations.
Mesa Laboratories reported revenue of $62.3 million for the second quarter of fiscal 2027, which ended on 30 September 2026, a 2.6% increase on the prior year. The company also posted sharply higher operating and net income and a lower leverage ratio.
The company issued its first full-year guidance for fiscal 2027. It expects revenue of $250 million to $255 million and adjusted EBITDA of $66 million to $68 million. It also detailed a savings and restructuring plan launched in October.
For quality and regulatory readers, the most notable disclosure is that an FDA inspection of the company's biological indicator plant in Bozeman, Montana, in September closed with no Form 483 observations. A Form 483 is issued by FDA investigators at the end of an inspection when they find conditions that may breach the Federal Food, Drug, and Cosmetic Act.
The information comes from the company's results announcement. The summary available does not give the scope of the inspection, the products covered or further detail on the restructuring plan.
What it means for your team
- Sterilisation and contamination-control teams relying on Mesa's biological indicators can note that the Bozeman plant's September FDA inspection produced no Form 483 observations.
- Supplier-quality teams may wish to record the clean inspection outcome in their vendor files, while noting that the scope of the inspection has not been disclosed.
- The October restructuring plan is worth watching for any effect on supply or service continuity, although the available information gives no detail on this.
Company's press release (SEC filing): Mesa Laboratories Inc /Co/ ↗
Article written by VigiEye from the official source (Mesa Laboratories Inc /Co/). Claims are the company's own. AI-assisted; check the source before acting.