Why do you need to be USFDA Inspection Ready?
USFDA Inspectors take an Oath of Allegiance to the US Government and swear to uphold the Federal Food, Drugs and Cosmetic Act. They are very serious about protecting public health and always complete very thorough inspection. USFDA Inspectors are highly skilled in investigational and communications techniques and how to best elicit information, especially where there is a potential issue. They are food safety experts trained in good manufacturing practice and Codes of Federal Regulations. Their skill set is often seen to be remarkable.
After an inspection, FDA Officials may issue FDA 483 and even a warning letter.
The FDA Agency is disclosing inspection information related to facilities that manufacture, process, pack, or hold an FDA-regulated product. According to the FDA Agency disclosure of the compliance status of company Inspections helps to provide the public with a rationale for the Agency’s enforcement actions and will also help to inform public and industry decision-making, allowing them to make more informed marketplace choices and help to encourage compliance. Inspections are classified to reflect the compliance status of a company and based upon findings identified during an inspection.
Disclosure of compliance information, 483 citations and warning letters can lead to negative publicity with adverse media reaction and loss of customers.
Knowledge & advance preparation is key to a successful USFDA inspection. It is important to have a good preparation plan and the resources necessary to facilitate an FDA Inspection.
There are very significant differences in how EFSA and local regulatory authorities’ vs USFDA regulatory inspections are conducted and communicated.
As well as ensuring compliance to Codes of Federal Regulations your organization needs to know how to interact with USFDA Inspectors, manage the audit room, answer questions effectively and how to avoid or respond to 483s.
What can Global Quality Consulting do to help you in the FDA Inspection Process?
”FDA Inspection Readiness Guidance Training for Human Food”
This one-day training is intensive, comprehensive training addressing aspects of FDA Inspection Readiness to include:
- The USFDA Regulatory framework for human food with reference to the relevant Codes of Federal Regulations
- FDA Inspection reports, 483s, Warning Letters, Import Alerts, Recalls and other Enforcement Actions.
- Brief overview of FSMA and how it related to other food related CFRs
- Key regulatory requirements & USFDA areas of focus
- Overview of computerized systems and electronic signature
- Overview of Food Defense Plan
- The USFDA Inspection Process
- Labelling – allergens, ingredients, food and color additives, food contact substances, and labeling requirements https://www.fda.gov/Food/IngredientsPackagingLabeling/ucm2006844.htm
- How to prepare for FDA Inspection
- Inspection Logistics: front room, back room set up
- Development of checklists and gap analysis to CFRs
- Preparation—Selecting and Training SMEs
- Meeting and greeting the Inspector
- The Inspection Process
- Do’s and don’ts
- How to answer difficult questions
- The Inspection Close out
- How to respond to a 483