FDA 483 - InvaTech Pharma Solutions, LLC - May 13, 2026
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An FDA inspection of InvaTech Pharma Solutions, LLC in East Brunswick, NJ, a drug manufacturer, revealed multiple significant deficiencies. These included inadequate sampling of high-risk components, failure to prevent objectionable microorganisms in non-sterile products, and issues with equipment design. Additionally, the firm lacked proper qualification of laboratory standards, failed to conduct annual visual inspections of retain samples, and exhibited poor material handling and storage practices.
ID · 16a6ca1f-3bac-43c9-9521-0ccf5e0dd14c