Enhancement Medical received a warning letter for failing to document supplier evaluations related to production of the Expression intranasal splint.

The Wauwatosa, Wisc., company’s procedures require a new vendor qualification form for potential suppliers, contractors and consultants. However, such a form did not exist for a contract manufacturer, contract testing facility, stem sterilizer or raw material supplier for hyaluronic acid, according to the June 4 warning letter posted online.

Enhancement had not performed an internal audit since it began operations in 2012, the letter says. The company’s procedure calls for such audits on a “routine basis.”
The FDA also cited Enhancement for failing to submit a report for a product removal. “Your firm made a decision in August 2013 to contact customers and exchange product with a lower gel weight that correlated with a significant increase in complaints of excessive swelling and/or pain experienced by patients,” the letter says.

Another citation notes the company does not test finished product to ensure that a requirement for a concentration specification is met. Enhancement lacks a host of written corrective and preventive action requirements, including ones for investigating the cause of nonconformities, verifying and validating CAPAs and submitting relevant information to management.

Meanwhile, Enhancement “routinely closes complaint records” without evaluating them for reportability, the letter says. Examples include complaints about:

• A patient with hard nodules after injection of the product. “The adverse event form indicates Vitrase was administered without resolving the nodules,” the letter says. The complaint was closed without information on the patient’s outcome;
• A patient with a “foreign body delayed reaction and nodule under the eye.” The adverse event form indicates prednisone was administered and a follow-up was set for 30 days. However, there is no evidence of a follow-up and the complaint was closed; and
• A patient with “extreme swelling” after injection of Expression. The complaint was closed without additional information on the patient’s outcome.

The letter goes on to note that Enhancement did not process complaints in a timely manner and did not complete separate complaint records for complaints on multiple lots or multiple patients. Additional citations stemming from the Dec. 16, 2013, through Jan. 15 inspection related to medical device reporting.

Enhancement did not respond to a request for comment by press time.

Devicemakers are outsourcing more and more of their critical operations and materials, trying to wring out costs and improve their profitability. The unintended consequence? A much, much greater risk of supplier control violations. Prevent these violations by purchasing Device Supplier Controls today!