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 regulations can be difficult for clients to navigate and a firm's failure to comply with applicable requirements may have devastating effects. FHI prepares clients for FDA inspections, prepares clients for 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. Invaluable to FHI clients is that Christine M. Humphrey, head of FHI’s Food, Drug and Cosmetic Team, personally has almost 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 FHI provides:
Audits/Inspections
The complexity of these various regulations can be difficult for clients to navigate and a firm's failure to comply with applicable requirements may have devastating effects. FHI prepares clients for FDA inspections, prepares clients for 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. Invaluable to FHI clients is that Christine M. Humphrey, head of FHI’s Food, Drug and Cosmetic Team, personally has almost 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 FHI provides:
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 oversight of contract services (manufacturing, testing)
- Document system development/review
- Quality system evaluation/development
- Computer Systems - Data Integrity / Electronic Records and Signatures
