FDA’s Office of Regulatory Affairs has released the most frequently cited inspectional observations for fiscal year 2017. Among the items on the spreadsheet are food safety hazards, failure to clean, sanitation records, corrective action plan, and lack of sanitation.
“These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.” – FDA
The following are the top five (most frequent) observations.
- 5. Contamination: Cleaning and sanitizing operations for utensils and equipment not conducted in a manner that protects against contamination of food, food contact surfaces and food packaging materials.
- 4. Failure to implement HACCP plan procedures.
- 3. Facility not constructed in a way that enables floors, walls and ceilings to be adequately cleaned; buildings, fixtures and other physical facilities not kept in sanitary condition.
- 2. Sanitation monitoring: Sanitation conditions and practices not monitored with enough frequency to be in conformance with CGMP.
- 1. Pests: Lack of effective pest exclusion from processing areas and contamination of foods, and failure to provide adequate screen against pests.