Five Essential Tools For FDA Compliance

The FDA has made available tools which you can use to stay up-to-date with the agency’s actions in our industry. Below are five informational tools that will help you prepare for the next inspection.

#1: Warning Letters – If you are interested in seeing the Warning Letters issued by the FDA, go to: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm. You can search by company name, date, etc. Warning Letters are serious compliance actions. By reviewing the Warning Letters, you can see the areas that are getting significant FDA emphasis right now.

#2: Inspection Violation Summaries – You can see summaries of the different violations noted by the FDA at: http://www.fda.gov/ICECI/EnforcementActions/ucm255532.htm#drugs. This helps us to see the most frequent violations found, along with descriptions of each violation. This information is also available to download in a Microsoft Excel (.xls) format.

#3: Company Search for 483s – You will want to know if the FDA has published any of your inspection results on the Internet. Go to: http://www.accessdata.fda.gov/scripts/inspsearch/ and enter all or part of your company name. The far right hand column (“classification”) is an indication of the severity of the inspection:

• NAI – No Action Indicated (This is the classification you would like to see for your inspections.)

• VAI – Voluntary Action Indicated

• OAI – Official Action Indicated.

Keep in mind that not all inspections are posted on the Internet. State inspections as well as federal inspections that were handwritten are not included in the database.

#4: Check your FDA Registration and Listing – Despite correctly submitting the information to the FDA, many companies are finding that their registration and listing data are incorrect or incomplete. You can check your own status with these links:

• Check your registration at: http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm.

• Check your listing at: http://dailymed.nlm.nih.gov/dailymed/search.cfm.

Verify that your company’s registration is current and that all products are correctly listed.

#5: Mock Audit – You should periodically review your compliance status by conducting a mock audit. You should have a checklist to verify that your plant and files are in compliance. Use this checklist to determine what items need correcting while you still have time to make corrections.

It is very difficult to objectively audit your own performance. Consider using a knowledgeable and experienced person, who normally works outside the area being reviewed, to conduct the mock audit. The person should be trained to conduct an audit.

The FDA regulations require you to conduct an Annual Records Review. 21 CFR 211.180(e) states:

“Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. Written procedures shall be established and followed for such evaluations and shall include provisions for:

• A review of a representative number of batches, whether approved or rejected, and, where applicable, records associated with the batch.

• A review of complaints, recalls, returned or salvaged drug products and investigations conducted under § 211.192 for each drug product.”

As long as you are doing the mock audit, you should document the Annual Records Review. Please contact me if you need a sample mock audit protocol (free for GAWDA members), a sample Annual Records Review documentation form (free for GAWDA members), mock audit training (free for GAWDA Medical Gas Program Members), or if you would like to schedule a mock audit from someone outside your company.

Gases and Welding Distributors Association
Thomas Badstubner Meet the Author
GAWDA’s FDA & Medical Gases Consultant Thomas L. Badstubner is president of AsteRisk LLC in Blackstone, Massachussets. Members can reach him at 508-883-0927 and tom@asteriskllc.com.