Quality Audits

Preparing for an FDA visit

Recent comments by FDA’s Duane Sylvia in the Spring 2004 issue of Welding and Gases Today (“Outlook For Medical Gases”) indicate that once FDA releases the new Medical Gas guidance document, our industry can expect to see an increase in inspection activity. To many medical gases manufacturing firms, a visit by an FDA inspector can be a nerve-racking event. Many companies do not have written procedures and have not organized themselves to manage an FDA inspection. Preparing for an FDA visit to your facility, and knowing how to protect your rights during the process, can be a key aspect of a successful outcome to an inspection.

The first part of the inspection process, inspector preparation, does not occur at the manufacturing site. Here the FDA inspector reviews your file, looking at past inspections and other information in the file. A key document, the Establishment Inspection Report, or EIR, is a detailed report and inspector notes from past inspections. Under federal law, firms can obtain a copy of their EIR through the Freedom of Information Act. We recommend every firm go through this process and learn what FDA has on file about your business.

The second phase is the site reception. An FDA inspector must identify themselves to the firm and present a form 482, Notice of Inspection. During this phase, they will be forming a mental image about your housekeeping and how you handle their arrival. Every firm should have someone assigned to handle an FDA inspection, along with several alternates designated in case the primary person is unavailable. Make sure your receptionist, or counter people, know whom to contact, and how. While getting settled in, FDA may request a plant tour. Here they are forming some mental impressions about your facility, your state of control, and what areas they may want to probe for non-conformances. Always assign someone to escort FDA at all times, and have someone take notes throughout the inspection, including writing down each question asked by FDA.

Once they have been received, provide the inspector a “sanitized” area, or office, to work from. This area should not have access to your network, your files, nor be near an area where FDA can overhear “water cooler” conversations. Next, have the inspector state the purpose of their visit, what areas they intend to review, and what documents they would like to see. This will help you organize the documents and alert areas such as the fill room or lab.

The third phase is the actual inspection itself. The FDA will ask to review regulated records to access compliance. Records FDA is entitled to review include your SOP manual, fill logs, prescription files, calibration and maintenance records, net contents verifications, label records, lot distribution records, and employee qualification and training files. There are records FDA is not entitled to review, which include pricing and contract files, personnel records, and sales and financial records. FDA is entitled to make copies of records, and for each record copied for FDA, you should make a copy for an inspection file of your own.

The next phase is task observation of your work force manufacturing medical gases. FDA has learned that the majority of medical gas errors are the result of untrained employees, or employees not following procedures. More and more, we see FDA inspectors, once they have read your procedures, observing the work force and asking questions to determine if your people are competent in cGMP requirements and your procedures. FDA cannot make a firm fill gases just so they can observe; however they do have the right to come back when that operation is scheduled. Many firms, as an accommodation to move the inspectional process along as quickly as possible, will go ahead and fill. That is entirely up to you.

The final phase is the closing meeting. Here the FDA inspector will recap the inspection and their findings, including any recommendations. FDA typically presents their findings in a Form 483, Notice of Inspectional Findings. You should take careful notes during the presentation of a 483, including any clarification or recommendations the inspector volunteers. If there are technical or factual errors in the 483, attempt to have the inspector fix them.

We recommend firms respond to all 483s within 15 working days. If FDA decides to issue a Warning Letter, any comments from the firm inside this 15-day window must be considered by the agency when writing the Warning Letter.

Gases and Welding Distributors Association
Meet the Author
GAWDA Medical Gases Consultant J. Robert Yeoman is managing director of B&R Compliance Associates LLC in Lehigh Valley, Pennsylvania. Members can reach him at 610-837-6782 and at bob.yeoman@brcompliance.com.