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"Your firms corrective actions only included scrapping devices in inventory and increasing the cleaning frequency of the [redacted] machine to prevent excess silicone from migrating to the luer connector, despite receiving 221 complaints and filing 177 [medical device reports (MDR)] for the disconnection of the NAMIC Angiographic Control Syringes from manifolds which impact patients and clinicians, including one (1) MDR # 3015910259-2025-00109 involving the injection of air into a patient (Complaint # [redacted] dated [redacted]) and one (1) MDR # 3015910259-2024-00045 involving biohazard exposure of a clinician (Complaint # [redacted] dated [redacted])." Furthermore, Medline Industries was cited for other violations, including failing to maintain schedules for adjusting, cleaning, and performing other equipment maintenance to ensure compliance with manufacturing specifications

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Stable Gastric Pentadecapeptide BPC 157 in Trials for Inflammatory Bowel Disease (PL-10, PLD-116, PL 14736, Pliva) Current Pharmaceutical Design Comprehensive review of BPC 157 clinical development for inflammatory bowel disease including ulcerative colitis trials, demonstrating mucosal healing and anti-inflammatory effects across multiple organ systems

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