ALBANY, Ore. — In response to a Food and Drug Administration warning letter, Tec Labs announced on Thursday that the company plans to work with the agency regarding its StaphAseptic first-aid antiseptic and pain-relieving gel.
The FDA on Wednesday issued a total of four warning letters, including the one to Tec Labs, to companies that manufacture and market products claiming to prevent infection from methicillin-resistant Staphylococcus aureus bacteria, or MRSA.
“Tec Labs has remained in good standing with the FDA for 30 years, ensuring the products they manufacture and market meet the regulations appropriate for their category,” the company stated in a release. “Acting in complete agreement that MRSA prevention claims should be clear, accurate and proven based on established regulations, the company will take steps necessary to meet the agency’s primary concern for public health and safety.”
The FDA has provided letter recipients 15 working days from April 18 to respond to the letter.