The FDA warned ProSun International LLC about several manufacturing quality issues related to its sunlamps and tanning beds.
The Food and Drug Administration said an August inspection uncovered multiple quality problems, including the firm’s failure to establish procedures for finished device acceptance and inadequate corrective and preventive action procedures. The findings are in a warning letter to St. Petersburg, Fla.-based ProSun that was posted to the FDA’s website Nov. 14, but dated Oct. 25.
ProSun received an earlier FDA warning letter over its tanning beds in September 2015.
Warning letters are a good indication of the Food and ...
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