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Home » FDA Cites Electro Medical for cGMP Violations in Two Warning Letters
FDA Cites Electro Medical for cGMP Violations in Two Warning Letters
September 23, 2005
The FDA has issued warning letters both to Electro Medical and to one of its contractors, Ms. Norva Parker, alleging the company has violated various current good manufacturing practices (cGMP) in the manufacture of the Stim Flex Model 400 and the Stim Flex Model 400A transcutaneous electrical nerve stimulator (TENS), used for pain relief.