Maison Blanche LLC – FDA Warning Letter, Sep 19, 2023
This FDA Warning Letter, dated September 14, 2023, was issued to a firm registered as a manufacturer of OTC drug products, specifically Hand Sanitizer Nº93 Maison Blanche. The letter details the firm's failure to respond to multiple electronic and phone requests for records and other information, initiated on August 16, 2022, pursuant to section 704(a)(4) of the FD&C Act.
The FDA attempted contact on August 16, 2022, August 31, 2022, October 24, 2022, February 6, 2023, September 6, 2023, and September 12, 2023. Despite an email from the firm on October 26, 2022, acknowledging registration renewal, no response to the records request was provided. The failure to permit access to or copying of records as required by section 704(a) is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)).
The FDA stated that due to the firm's non-response, there is no indication of the quality assurance level for drugs manufactured at the facility. The letter requires a response within 48 hours to confirm/update registration/
ID · f110c12d-4cab-4bce-a7cf-df574e9570dc
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