For nearly a decade, an oxygen refiller may not have tested its products for purity, and the 5-year expiration dates put on labels may be fiction, according to an FDA warning letter sent to the Norman, OK plant of Oklahoma Respiratory Care.
The June 18 warning letter, posted this week to the FDA website, said inspectors found a list of shortcomings during their October visit to the company's plant.
In fact, employees told FDA inspectors they had never received training on how to do identity and perform quality inspection on incoming oxygen products, and so never tested them, even though they indicated on batch records that they had.
A quality control employee said he didn't review batch records to see that products met specifications, including 59 lots sold from January through Oct. 18 of last year. A review of records dating back to 2003 provided no proof that any products had been tested.
Finally, Oklahoma Respiratory is putting 5-year expiration dates on its products without any stability testing that would indicate they will last that long.
The respiratory care industry is booming in the U.S. Just this week, Linde AG of Germany, a global maker of gas and oxygen products for both healthcare and industrial uses, agreed to pay about $4.6 billion to acquire Lincare Holdings. It said the acquisition will allow it to tap into the growing U.S. market for home healthcare products provided by the Clearwater, FL, company.
- read the warning letter