Drugs

14 GenoGenix Inspection Observations

FDA has released the form FDA-483 issued following a 7/14-7/19 inspection at GenoGenix, a Boca Raton, FL, outsourcing facility. The 14 inspection observations were:

failure to include validation of the process in procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
failure to have in writing and fully follow responsibilities and procedures applicable to the quality control unit;
failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
aseptic process areas are deficient regarding the system for monitoring environmental conditions;
failure of laboratory controls to include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, closures, in-process materials, and drug products conform to appropriate standards of identity, strength, quality, and purity;
failure of reprocessing procedures to include steps to be taken to ensure that reprocessed batches will conform with all established standards, specifications, and characteristics;
failure of buildings used in the manufacture, processing, packing, or holding of a drug product to have suitable construction to facilitate cleaning, maintenance, and proper operations;
reports of analysis from component suppliers are accepted in place of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals;
failure to prepare batch production and control records for each batch of drug product produced, including complete information relating to the production and control of each batch;
failure to exercise strict control over labeling issued for use in drug product labeling operations;
failure to establish control procedures for those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product;
employees engaged in the manufacture, processing, packing, and holding of a drug product lack the education, training, and experience required to perform their assigned functions;
failure of the labels on the facility’s drug products to include information required by specific provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA); and
failure of the containers of the facility’s drug products to contain information required by specific provisions of the FFDCA.

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