Biotechne, Inc. – FDA EIR, Jun 20, 2017

An FDA Level I abbreviated inspection of Biotechne, Inc., a manufacturer and contract manufacturer of controls, buffers, calibrators, and standards for the in-vitro diagnostic market, was conducted at their Devens, MA facility from July 19-20, 2017. The inspection was performed under the regulatory framework of CP7382.845A, specifically targeting medical device manufacturing operations, which fall under FDA jurisdiction as per section 201(h) of the Federal Food, Drug, and Cosmetic Act.

The scope of the inspection covered key quality system areas including Management Controls, Corrective and Preventive Actions (CAPA), and Production & Process Controls (P&PC). Investigators reviewed aspects such as the firm's quality manual, internal audits, non-conformances, customer complaints, device master and history records, employee training, process validation, and calibration. Notably, the inspection concluded with no significant Good Manufacturing Practice (GMP) deficiencies identified, and no observations were listed on Form FDA 483, indicating a satisfactory level of compliance. The only required action was a voluntary commitment by Biotechne, Inc. to update their FDA registration to reflect the company's recent name change from Bionostics. The report highlighted the company's timely provision of documents and responses, reinforcing a positive inspection outcome.