Independent Associate, Specialty: cGMP Inspections: FDA Regulatory/Compliance: seafood manufacturers, low acid can food manufacturers (LACF), acidified food manufacturers (ACF), private testing laboratories, finished pharmaceutical manufacturers, active pharmaceutical ingredient manufacturers (APIs), over the counter drug (OTC) manufacturers, medical device manufacturers, tanning salons, blood banks, blood donor centers.
Mr. Gifford Whitehurst is a former senior FDA investigator with 27 years of FDA experience.
United States Food and Drug Administration (FDA), Baltimore, MD
Investigator/Consumer Safety Officer, 1985 to 2012
Conducted numerous establishment inspections of various domestic food storage facilities/warehouses, food manufacturers, seafood manufacturers, low acid can food manufacturers (LACF), acidified food manufacturers (ACF), private testing laboratories, finished pharmaceutical manufacturers, active pharmaceutical ingredient manufacturers (APIs), over the counter drug (OTC) manufacturers, medical device manufacturers, tanning salons, blood banks, blood donor centers etc.
Conducted numerous and various field examinations of various imported commodities.
Prepared numerous establishment inspection reports, FDA-482s, FDA-483s, FDA-484s, affidavits, affirmations, investigation reports, import and domestic sample collection reports, warning letters, untitled letters, import sampling notices, detention letters, refusal letters, recall initiation reports, recall termination reports, recall audit check reports etc.
Collected numerous imported and domestic samples for various FDA lab analysis. In addition, collected numerous documentary samples to document interstate commerce and for regulatory action consideration.
Conducted numerous food borne illness investigations, food product tampering investigations, fraud investigations, recall audit investigations etc.
As acting import and domestic compliance officer, detained and refused numerous imported products, as well as forwarding warning letters and untitled letters to various non-compliant firms. In addition, responded to consumer inquiries and firm’s responses to various compliance actions.
Performed electronic review of numerous imported entries.
Relevant FDA Courses Attended and Successfully Completed:
- Basic Food & Drug Law & Evidence Development
- Compliance Law
- Drug Manufacturing & Quality Control
- Active PharmaceuPre-Approval Inspectionstical Ingredient Manufacturing
- Pre-Approval Inspections
- Acidified Foods
- Food Microbiological Control
- Investigating Foodborne Illnesses
- Specialized Interviewing Techniques
- Seafood HACCP Regulator Course
- Basic Course in Seafood Hazard Analysis and Critical Control Point Theory and Practical Applications