FDA 483 - McCallum Manufacturing Limited - July 28, 2017

McCallum Manufacturing Ltd, an OTC and Cosmetics manufacturer in Barnsley South Yorkshire, was cited with 11 observations during an FDA inspection from July 24-28, 2017. The inspection revealed significant deficiencies in manufacturing process validation, quality agreements, equipment cleaning validation, record-keeping, material testing, and overall quality assurance procedures. These issues indicate a lack of robust quality control and documentation practices for their (b)(4) US products.