Potty MD was cited by the FDA for not using a quality system (QS) for its bed-wetting alarms, according to an Aug. 23 warning letter.
The firm failed to implement these procedures prior to the pre-announcement of an FDA inspection June 11, the letter said. No devices should have been manufactured or distributed without a QS in place, it said.
Preston Smith, president of Potty MD, told D&DL the company recently bought the business and was not aware that it was subject to QS regulations. He said the company is addressing the agency’s concerns and will respond to the letter shortly.
The warning letter can be accessed at www.fda.gov/foi/warning_letters/s6489c.pdf.