75 Executive Drive, Suite 114, Aurora, Illinois, USA - 60504

Phone : (630) 270-2921
E-mail : info@fdahelp.us

FDA Inspection – FDA 483 warning letter

FDA inspect establishments that manufacture, process or pack FDA regulated products like medical device, drug, cosmetic, food etc. FDA conduct random inspection with short notice to verify the GMP compliance. FDA ORA (office of Regulatory Affairs) is responsible for field inspections.

FDA Medical Device Audits are based on 21 CFR 820 regulations. for a small medical device establishment, FDA may schedule an inspection for 2-3 days and select 3 or 4 areas or complete quality management system for inspection. After inspection if any non-conformities (non-compliance) found, FDA will issue an Establishment Inspection Report (EIR) with observations listed on form FDA 483.

FDA disclose inspection reports to public via FDA website, this is crucial for small medical device, food and drug companies. Private label distributors, labelers and wholesale distributors always consider the establishment history and enforcement actions while selecting a manufacturer or contract manufacturer, it is also a part of their quality management system and vendor selection procedure. FDA warning letter or enforcement action will reduce the negotiation power of your establishment.

How to avoid FDA 483 warning letter?

The only solution to avoid FDA warning letter is to comply with FDA GMP regulations and always prepared for an FDA inspection with proper documentation. For small medical device establishments who manufacture class 1 or class II medical devices with 20-25 employees it is not always feasible to keep a full time quality management personnel. In such situation, it is advisable to hire experienced third party quality consultants who can provide proper guidance and help with documentation, internal audit, training, mock audits etc.

How LMG can help with FDA inspection?

Liberty Management Group LTD, is a Leading medical device GMP consultant based at greater Chicago area with experience in FDA 21 CFR 820 regulations, CE Marking and ISO 13485.

We can help you to:

  • Prepare quality manual
  • Prepare Quality system procedures
  • Conduct internal audit
  • Conduct training
  • Conduct MRM Meating
  • CAPA documentation
  • FDA Audit support
  • Maintain your quality system up-to-date

Hand Sanitizer GMP Certificate

Contact Us

75 Executive Drive, Suite 114
Aurora, Illinois, USA - 60504
Phone : (630) 270-2921
Fax : (815) 986-2632
E-mail : info@fdahelp.us