Glicerinas Industriales, S.A. de C.V.

WARNING LETTER Glicerinas Industriales, S.A. de C.V. MARCS-CMS 633340 — June 13, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Alfredo Moran Sanchez Recipient Title Director Glicerinas Industriales, S.A. de C.V. Calle Uranio No. 80 Col. Arenales Tapatios 45188 Zapopan , Jal. Mexico Issuing Office: Center for Drug Evaluation and Research | CDER United States Warning Letter 320-22-15 June 13, 2022 Dear Mr. Sanchez: The U.S. Food and Drug Administration (FDA) notified your site, Glicerinas Industriales, S.A. de C.V. (“GLINSA”), FEI 3016420687, at Calle Uranio No. 80, Col. Arenales Tapatios, Zapopan, of a planned inspection of your drug manufacturing facility from May 16 to May 20, 2022. Your firm refused the pre-announced inspection during a phone call with representatives from the Office of Regulatory Affairs on February 24, 2022, and written notification received by your firm via United Parcel Service (UPS) on March 23, 2022. Your firm is a supplier of drug components (e.g., glycerin) to manufacturers of finished drug products distributing to the U.S. market. The use of glycerin contaminated with diethylene glycol (DEG) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Testing of Glycerin for Diethylene Glycol for FDA’s current thinking regarding current good manufacturing practice (CGMP) requirements when manufacturing drugs containing glycerin at https://www.fda.gov/media/71029/download . Under section 501(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(j), your drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment that delays, denies, or limits an inspection, or refuses to permit entry or inspection. See FDA’s guidance document, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection, at https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm360484.pdf . FDA placed your firm on Import Alert 66-79 on June 9, 2022. Until FDA is permitted to inspect your facility and confirms compliance with CGMP, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Glicerinas Industriales, S.A. de C.V., Calle Uranio No. 80, Col. Arenales Tapatios, Zapopan, into the United States that appear to be adulterated are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). After you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices, and/or submit a request to schedule an FDA inspection. Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3016420687 and ATTN: Bill Fowler. Sincerely, /S/ Francis Godwin Director Office of Manufacturing Quality Office of Compliance Center for Drug Evaluation and Research Content current as of: 06/21/2022 Regulated Product(s) Drugs