Richard-Allan Scientific Company – FDA EIR, Aug 26, 2015

An FDA inspection of Richard-Allan Scientific Company, a manufacturer of Class I reagents, was conducted from August 24-26, 2015, in Kalamazoo, MI. This for-cause inspection followed a Class I recall of 10% Neutral Buffered Formalin. The primary finding, documented in an FDA 483, cited deficiencies in complaint handling, specifically under 21 CFR 820.198(a).

The firm failed to adequately investigate complaints. For instance, regarding an unreported market withdrawal of Dehydrant due to an atypical odor and alleged staining issues, the company lacked documented evidence to support its claim that the product still functioned as intended. Investigations did not assess customer-specific staining protocols. Similarly, for the recalled 10% Neutral Buffered Formalin, which risked reduced tissue fixation, investigations failed to determine if patient tissue specimens were lost—a potentially MDR-reportable event. The firm also experienced delays, sometimes several months, in processing complaints. Additionally, the unavailability of retain samples hampered thorough investigations and confirmation of recall scopes for affected products.

Management elected not to annotate the observation but committed to providing a written response to the FDA within 15 business days, outlining corrective actions for these significant compliance issues.