The Food and Drug Administration (FDA) conducts inspections and assessments of regulated facilities to determine a firm’s compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act.  This usually involves an investigator visiting a firm’s location.  You will not always be informed about an FDA inspection in advance, so you need to be fully prepared if you want to avoid those pesky warning letters and citations! 

The FDA (Food & Drug Administration) has gotten more stringent with their acceptance criteria, especially when it comes to food and drug or medical device companies.  A single FDA Inspection may include multiple activities.  For example, a single inspection might cover drug quality assurance, and over the counter drug evaluation.

It is sure to happen eventually; an FDA Inspector will visit your facility.  According to the Department of Health and Human Services, approximately one in every five food and beverage manufacturers will undergo an inspection in any given years, so you can be sure your turn is coming. 

How Does the FDA Choose Which Facilities to Audit?
FDA Audits can take place for several reasons; your facility might be randomly selected, or the inspector may be following up to ensure problems from the past have been corrected.  They may also be investigating the source of a contamination incident or responding to a safety complaint.   Whatever the reason behind the inspection, nothing is off limits; expect every zone of production to be visited.  Samples may be collected from any stage of processing, and past safety records will be reviewed.  Since the inspection can happen at any time, you need to be prepared at all times. Here are a few tips to help you prepare:

Perform an Internal Quality Audit
Internal quality audits help you to identify possible compliance problems and areas of concern, so you can adjust procedures and processes as required.  An internal auditing program is ideal for ensuring that individual processes and your entire quality system does meet FDA process validation and compliance requirements.

Review Quality Procedures and Practices
The FDA inspector or officer will review your quality system, so familiarize yourself with applicable regulations, guidance documents and manuals. It isn’t enough to draft procedures that comply with FDA approval requirements.  Ensure that procedures align with the company’s manufacturing process and practices, since both will be reviewed and audited during the inspection.
Also review past warning letters and citations, non-conformation reports, batch reports, clinical trial and product performance reports, risk assessments, training records and operating procedures. Compliance to FDA 21 CFR Part 820 is required for medical device companies seeking FDA approval in the U.S., so make sure you have everything needed for demonstrating regulatory compliance.

Ensure Your Team is Fully Prepared
FDA inspections are stressful, even when you’re prepared for them.  Consider, looking into training courses for FDA process validation, quality assurance and industry best practices. Use mock inspections to make sure everyone knows what to expect and how to handle it.
Define roles and responsibilities for employees who will be involved in the inspection, and coach them on answering questions directly and responding specifically to what is asked.

Don’t Panic Before an Inspection
A little panic is normal, but keep it under control:

  • Inform everyone about the pending inspection but continue with routine production and regular business practices instead of changing them before the inspector arrives.
  • Designate an area for interviews, data collection and evaluation. Also assign a specific team member to accompany the inspector/officer always during their tour of the premises.
  • When the inspector points out issues that need correction, avoid trying to fix them during the inspection.
  • If you don’t understand the inspector’s comments, ask for clarification instead of trying to guess at what they mean.
  • If you don’t agree with observations, avoid being argumentative or defensive. You must follow FDA rules whether you agree with them or not, but calmly state your case with supporting objective evidence if possible.
  • Be honest while answering questions, and if you don’t know the answer, admit it instead of making up a response. Provide supporting documentation and records for all your responses.

As a leader in Scientific Equipment Repair and medical equipment calibration, Scientific Instrument Center works with many corporations, universities, and hospitals providing the highest level of laboratory services. 
Keeping your lab equipment in peak condition is vital if the results are going to be accurate and reliable.   Scientific Instrument Center (SIC) is your trusted company for laboratory equipment repair and maintenance services.  If you have questions about your laboratory equipment and would like to discuss options for repairing or maintaining the equipment, please contact us at (614) 771-4700.

Our skilled staff members understand the nuances of instrument calibration and the manufacturers train our technicians, so any inspections we make mean your equipment is to quality standards.   For more than 30 years, SIC has served businesses that use a wide variety of diagnostic and scientific equipment.  We are specialists.

Get a free consultation.  Call (800) 686-8965