Shanghai Institute of Pharmaceutical Industry

WARNING LETTER Shanghai Institute of Pharmaceutical Industry MARCS-CMS 574821 — August 29, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Ms. Hongjuan Pan Recipient Title Testing Laboratory Director Shanghai Institute of Pharmaceutical Industry No. 285 Gebaini Road Pudong District Shanghai Shi , 201203 China Issuing Office: Center for Drug Evaluation and Research 10903 New Hampshire Avenue Silver Spring , MD 20993 United States Warning Letter 320-19-40 August 29, 2019 Dear Ms. Pan: The U.S. Food and Drug Administration (FDA) notified your site , Shanghai Institute of Pharmaceutical Industry at No. 285 Gebaini Road, Pudong District, Shanghai, of a planned surveillance and pre-approval inspection of your drug product testing facility from November 29 to December 4, 2018. Your firm refused the pre-announced inspection in a written response to the FDA China Office on December 4, 2018. Your firm is listed as a contract testing laboratory that provides active pharmaceutical ingredient (API) characterization and/or identification testing to support multiple abbreviated new drug applications (ANDAs). Under section 501(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(j), drugs are deemed adulterated if they are manufactured, processed, packed, or held in an establishment and the owner, operator, or agent delays, denies, limits, or refuses an 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 . Until FDA is permitted to inspect your facility and confirms compliance with current good manufacturing practice (CGMP), this office may recommend withholding approval of any new applications or supplements listing your firm as a drug manufacturer. After you receive this letter, respond to this office in writing within 15 working days. Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov or mail your reply to: Carrie Ann Plucinski Compliance Officer U.S. Food and Drug Administration White Oak Building 51, Room 4359 10903 New Hampshire Avenue Silver Spring, MD 20993 USA Please identify your response with FEI 3002808132. Sincerely, /S/ Francis Godwin Director Office of Manufacturing Quality Office of Compliance Center for Drug Evaluation and Research Content current as of: 10/01/2019 Regulated Product(s) Drugs