Drugs

15 Observations in Qualgen FDA-483

FDA has released the FDA-483 with 15 observations issued following a 4/29-6/15/21 inspection at Qualgen, an Edmond, OK, outsourcing facility. The observations were:

failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products and to have the responsibilities and procedures applicable to the quality control unit in writing or fully followed;
procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, or followed;
failing to have written methods of cleaning or methods of processing to remove pyrogenic properties;
failing to establish and follow written procedures for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product;
failure of the quality control unit to review and approve changes to written procedures;
clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they perform;
laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, and purity;
separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient;
equipment used in the manufacture, processing, packing, or holding of a drug product is not of appropriate design or suitably located to facilitate operations for its cleaning and maintenance;
drug product closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use;
buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable size, construction, and location to facilitate cleaning, maintenance, and proper operation;
routine calibration of automatic, mechanical, and electronic equipment is not performed according to a written program designed to assure proper performance;
master production and control records are deficient in that they do not include complete manufacturing and control instructions and procedures;
labels of the outsourcing facility’s drug products do not include information required by regulations; and
the containers of the outsourcing facility’s drug products do not include information required by regulations.

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