Proactive FDA Inspection Preparation

In my Fall 2010 column, I wrote about a comprehensive FDA inspection strategy that included preplanning, professional conduct and post inspection actions. (Read “The FDA Investigator Is At The Door” at www.Welding& This article further explores the most effective things you can do to protect yourself in the pre-planning phase. If you carefully conduct your own mock-audit, you can quickly see if there are obvious areas needing improvement. Below are some items to consider during your mock-audit.

General Provisions:   Is the facility currently registered with the FDA? Confirm this at • Does the facility have a current and accurate Drug Product Listing? Confirm this at • Is the facility currently licensed with the appropriate state agency, and is a copy of the license available on site? • Are written standard operation procedures (SOP Manuals/Work Instructions) current? • Are lot numbers and expiration dates properly formulated?

Organization & Personnel:   Is the training documented for personnel to properly perform assigned duties? • Have all appropriate personnel received documented annual cGMP training?

Buildings & Facilities:   Is the lighting adequate in production areas? • Is it obvious where the full and empty cylinders are stored? • Has an area been identified as a quarantine area? • Are medical gases segregated from industrial gases? • Is the housekeeping satisfactory? Are restrooms clean?

Equipment:   Are fill lines and manifolds labeled appropriately? • Are product adapters controlled? • Are all thermometers calibrated annually? • Are all pressure and vacuum gauges calibrated annually? • Are daily vacuum gauge checks performed and documented? • Are flow meters and timers calibrated according to procedures? • Are scales calibrated annually? • Are the Servomex zero and span calibrations documented? • Are calibration (span & zero) standards certified?

Control of Components:   Do receipts for incoming bulk product list the product as medical grade? • Are bulk deliveries tested/released before use in medical products?

Production & Process Controls
Are proper fill records (on current form revision) completed as the work is performed? • Are pre-fill inspections documented for each lot? • Do all portable cryogenic containers have the proper fittings and are the fittings “tamper-proof”?

Labeling Control:   Are approved master labels available for all medical gases filled? • Are label inventory records completed according to procedures? • Are labels stored with limited access? • Are the label inventories correct and periodically reconciled? • Are medical containers properly labeled? Is all label text readable? Have labels been applied over other labels? • Are the 360-degree wrap-around labels used on cryogenic containers?

Holding & Distribution:   Does facility maintain distribution records which allow traceability by lot? • Does facility comply with first-in/first-out stock rotation procedures?

Laboratory Controls:   Are required tests (USP/NF) performed at the frequency required and documented properly?

Records & Reports:   Does facility retain records according to a records retention policy? • Does facility maintain a complaint file? • Does facility investigate complaints and take appropriate action? • Are entries on documents correct and made in ink? Are error corrections made properly? • Are all applicable spaces filled in correctly? • Are fill records initialed/signed by the filler and the analyst? • Are all fill logs released, signed and dated by an authorized reviewer?

Returned & Salvaged Drug Products:   Are all high pressure cylinders vented and vacuumed before refilling? (No HP product is reprocessed.)

Conclusion:  Though this is not a comprehensive audit, it can help you discover and implement opportunities for improvement before an FDA investigation. Contact me for a more comprehensive mock audit white paper.

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