P.A. Benjmin Manufacturing Co., Ltd..docVIP

P.A. Benjamin Manufacturing Co., Ltd. 1/29/13  Department of Health and Human ServicesPublic Health ServiceFood and Drug Administration Silver Spring, MD 20993  Warning Letter CERTIFIED MAIL WL: 320-13-07 RETURN RECEIPT REQUESTED January 29, 2013 Mr. Errol L.G. Powell Chairman P.A. Benjamin Manufacturing Co., Ltd. 95-97 East Street Kingston, Jamaica Dear Mr. Powell: During our May 5 through 11, 2012, inspection of your pharmaceutical manufacturing facility, P.A. Benjamin Manufacturing Co., Ltd., located at 95-97 East Street, Kingston, Jamaica, investigator(s) from the U.S. Food and Drug Administration (FDA) identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug product(s) to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP. We have conducted a detailed review of your firm’s response of May 24, 2012, and note that it lacks sufficient corrective actions. Our investigator(s) observed specific violations during the inspection, including, but not limited to, the following: CGMP VIOLATIONS Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Two examples of this violation include: Lot #JU83 of Infant Gripe Mix failed the pH specification. The range was (b)(4) to (b)(4), whereas the result recorded in the batch record was (b)(4). Lot # KM40 of Diphenhydra