Birchwood Laboratories LLC – FDA 483, Feb 13, 2026

Birchwood Laboratories, LLC, located in Eden Prairie, Minnesota, underwent an FDA inspection from February 9 to February 13, 2026. This inspection identified critical deficiencies in the manufacturer"s data management and quality control processes. The primary violations concerned the company"s facilities and laboratory systems. Specifically, investigators found that computers connected to essential testing equipment lacked restricted access. Laboratory personnel could modify system date and time settings, which compromises the reliability and integrity of analytical test results for over-the-counter drug products. Furthermore, the firm failed to properly qualify its data acquisition software, leading to a repeat observation where data could be manually deleted or manipulated. In the laboratory system, the firm’s stability program was found to be inadequate. While the program identified necessary testing parameters, it failed to reference or include the validated analytical methods required to perform those tests. This lack of clear methodology undermines the accuracy of data used to determine product quality and expiration dates. These observations were issued under the regulatory framework of Section 704(b) of the Federal Food, Drug, and Cosmetic Act. While the document does not represent a final agency determination, Birchwood Laboratories is expected to address these findings. The company must either discuss its corrective action plans with the FDA or submit a formal written response detailing how it will resolve these issues to ensure compliance with safety and quality standards.