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FDA 483 / Warning Letter

FDA WARNING LETTER

Receiving an FDA 483 or FDA Warning letter can be an alarming experience. Letters notify regulated industries about violations documented during FDA inspections or investigations, and typically pertain to products, practices, or processes, and can create alarm for recipients.

Compliance Insight can handle FDA 483 and Warning responses for industries across the life science market, including: medical devices, dietary supplements, drugs, clinical trials, and biologics. We also help prevent future 483 issuances by providing compliance training and administering mock inspections.

If you receive a 483 notice the letter will make clear when and how you must inform the FDA of your plan for correction. We urge you to seek assistance as soon as possible, so we can resolve your issue quickly and efficiently.

Experience & Capabilities

  • FDA Compliance Consulting

  • Project Management

  • FDA 483 / Warning Letter

  • Consent Decrees

  • Systems Monitoring

  • GXP Training

  • Product Submissions

  • Due Diligence

  • Product Reviews

  • Registration & Listing

  • Audits

  • Gap Analysis

  • Regulatory Strategies

  • Inspection Preparation

  • GMP Services

  • GCP Services

  • FDA Submissions

  • Clinical Development

  • Nonclinical Development
  • Risk Based Assessment

  • Combination Products

  • Staff Augmentation

  • Electronic Publishing

  • Program Design