A successfully completed FDA inspection carries enormous weight. Meeting its stringent requirements is not only the key to the world’s largest pharmaceutical market, the USA, but also the equivalent of an internationally recognized seal of quality. For a company like Heel, a positive FDA assessment is proof that its production processes are cutting edge and meet the highest international quality requirements.
“High marks from the FDA show that we are actively living up to our great responsibility as a manufacturer of medical products” says Dr. Ralf Aubeck, Head of Quality Assurance at Heel headquarters in Baden-Baden. “Passing an FDA inspection with no demerits is an uncommon occurrence in the pharma sector, and we owe our success to the highly committed, quality-conscious, and competent employees at our Baden-Baden production site.”
For six days, an experienced FDA expert inspected the production of oral ampoules, ointments, gels, suppositories, and liquid pharmaceuticals that are shipped from Baden-Baden to the USA, among other destinations. She took a close look at manufacturing procedures and quality assurance processes, examined the cleaning and sterilization of the facilities as well as the storage of products. The outcome: no complaints at all.
The routine inspection took place in the context of the FDA’s increasingly international inspection activities. It included checking for cGMP (current Good Manufacturing Practice). Audits often result in “483” nonconformance reports or sometimes in “warning letters,” which can lead to severe penalties including import bans. At Heel, however, the feared Form 483 remained blank.