FDA 483 - McCallum Manufacturing Limited - July 28, 2017
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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.
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- Human Foods Program
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ID · 2e89fa23-20a7-4a0b-9e6d-9ee86c064dfb