Management at Hospital Therapy Products failed to establish a quality plan, quality audits, or procedures for management reviews, a May 7-14 inspection of the firm’s Wood Dale, Illinois inspection revealed.
During a previous 2017 FDA inspection, the firm was also cited for failing to establish quality audits, but the firm has “continued to fail to conduct quality audits since the last FDA inspection,” the 483 says.
Corrective and preventive action activities were not properly documented as evidenced by three CAPAs that were initiated since the agency’s previous inspection.
The firm was also cited for failure to have a quality policy at the last inspection, and FDA inspectors were handed a document titled “Quality System Policies, Procedures and Requirements,” but the document failed to reference a quality policy, the 483 says.
“Your firm failed to have a quality manual and/or plan that describes and references the firm’s organizational structure and/or quality documents that will assure your firm’s compliance with quality policy,” the 483 says.
Another repeat observation from the 2017 inspection was that the firm failed to establish written management review procedures. Inspectors noted that on May 7, they were initially told that no formal management reviews had been held since the last FDA inspection.
In addition, numerous documents lacked a signature by a “quality designee.”
Read the 483 here: www.fdanews.com/10-10-19-hospitaltherapyproductsinc483.pdf.