FDA Form 483s, Complaints, and Regulatory Docs on NECC and 2012 Fungal Meningitis Outbreak

Original Request: 1. FDA Inspection Reports – Copies of any Form 483s and other inspection reports issued to NECC during this timeframe. 2. Complaints and Adverse Event Reports – Records of any complaints, adverse event reports, or safety concerns submitted to the FDA regarding NECC’s products. 3. Regulatory Correspondence – Copies of any correspondence between the FDA and NECC, or its representatives, regarding compliance matters, inspections, regulatory actions, or investigations. 4. Fungal Meningitis Outbreak Investigation – Documents related to the FDA’s role in investigating the 2012 fungal meningitis outbreak linked to NECC, including internal memos, reports, or other relevant materials.
Tags: Food, 483, 2012