The QMN Weekly Bulletin
Quality / Medical Devices / Regulatory Affairs / Inspections and Audits

Argentine Nebulizer Maker Warned On Cleaning, Material Handling Issues

Dec. 20, 2013

San Up, a Buenos Aires maker of piston and ultrasonic nebulizers, was warned by the FDA after cleaning shortfalls and other good manufacturing practice slip-ups.

Multiple areas of the company’s facility were not cleaned or maintained, according to the Nov. 25 letter posted online Dec. 10. San Up lacked a procedure to document cleaning requirements and activities for certain equipment used in its in-process testing, and the FDA inspector noticed certain items were not cleaned “and are openly exposed to the manufacturing environment.”

The letter also cited the company’s handling of incoming material. San Up’s procedure requires a sticker on each box of incoming material that is waiting for inspection. Another sticker indicates approval or rejection. “During the inspection, it was noted that several pallets of incoming material were missing the appropriate incoming material inspection stickers,” the letter says.

San Up’s complaint procedures came under scrutiny as its adverse event procedure does not discuss reporting events to the FDA. The company’s procedures also do not specify a group or person responsible for evaluating complaints.

Meanwhile, the FDA investigator’s review of corrective and preventive action reports found certain required signatures and dates were missing. It also found that San Up closed a CAPA before associated training was completed.

Additional citations note:

  • Management reviews were not conducted within the company’s specified time intervals;

  • San Up could not provide evidence that software programs were validated for their intended use; and

  • A form in the DHR for an ultrasonic nebulizer lacked production supervisor approval signatures.

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