Recipient: Shamrock Medical Solutions Group LLC .
Investigators from the 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 products 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. In addition, your firm mislabeled drug products causing them to be misbranded under section 502(b)(2) of the Act [21 U.S.C. § 352(b)(2)]. By introducing adulterated and misbranded drugs into interstate commerce you are in violation of section 301(a) of the Act [21 U.S.C. § 331(a)]. Specific violations observed during the inspection include, but are not limited to, the following: 1. Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by authorized personnel [21 C.F.R § 211.68(b)]. For example, repackaging technicians changed master labels of repackaged products, which resulted in product packages labeled with incorrect strength or incorrect spelling of the drug name. You then released these mislabeled drug products for distribution. Examples of incorrect labeling that resulted from technicians changing the master label include: Levothyroxine Sodium 150 mcg Tablet labeled as Levothyroxine Sodium 150 mg Tablet, and Metoclopramide 10 mg/10 ml labeled as Metroclopramide 10 mg/10 ml. Your firm included a proposal to revise the labeling system computer software to restrict technicians’ access to the master labeling program in the Corrective and Preventative Actions (CAPA) sections of four separate Incident Reports concerning mislabeled products. These proposals were signed and submitted for approval to your Quality Assurance Unit (QAU) on March 31, 2011. However, to date, your firm has not reported any corrective or preventive actions taken to address these violations. We also note that you did not follow your SOP S-0002.00-PROD “Master Production and Control Record,” which requires your Quality Assurance Unit (QAU) or designee to review each master production and control record before beginning repackaging and/or relabeling operations. These records include the drug product name, strength, and dosage form, as well as copies of each label. However, your QAU review was inadequate in that the error was not noted.
FDA District: Cincinnati District