FDA Inspections

Prepare with an Expert in FDA Inspections

FDA inspections come in many shapes and sizes - from HACCP compliance to GMP compliance covering foods, biologics, drugs and cosmetics to QSR regulations governing medical devices. Additionally, some inspections are "for cause," while others are routine.

The complexity of these various FDA regulations can be difficult for clients to navigate, and a firm's failure to comply with applicable requirements may have devastating effects. We prepare our clients for FDA inspections, with counseling on how to prepare for an FDA inspection, what materials are and are not for FDA inspection and copying, and how to respond to FDA-483 items and warning letters to avoid the negative results that may arise from an FDA inspection.

Our in-depth experience includes nearly 10 years of FDA field experience in the application of FDA laws covering all FDA-regulated products.

Here are some examples of the regulatory counseling that we provide for our clients:

Audits/Inspections:

FDA "mock" inspections (GMP, GLP, GTP, GCP)
Pre-Approval Inspection (PAI) readiness 
Participation in FDA inspections and close-out meetings
Preparation and assistance to FDA-483 responses
Preparation of responses to FDA Warning Letters

Quality Assurance:

Quality Assurance oversight of contract services (manufacturing, testing) 
Document system development/review
Quality system evaluation/development
Computer Systems - Data Integrity / Electronic Records and Signatures