GenoGenix, LLC — FDA 483 Findings

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the process.

Reports of analysis from component suppliers are accepted in lieu 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.

Your outsourcing facility has not submitted a report to FDA identifying a product compounded during the previous six months as required by section 503B(b)(2)(A) ofthe Federal Food, Drug, and Cosmetic Act (FD&C Act).

Your outsourcing facility compounds drug products using bulk drug substances that cannot be used in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they (a) are not used to compound drug products that appear on the drug shortage list in effect under section 506E of the Act and (b) do not appear on a list developed by FDA of bulk drug substances for which there is a clinical need.

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

Reprocessing procedures lack the steps to be taken to ensure that reprocessed batches will conform with all established standards, specifications, and characteristics.

The container of your outsourcing facility's drug products does not include information required by section 503B(a)(10)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Batch production and control records are not prepared for each batch of drug product produced and do not include complete information relating to the production and control of each batch.

Control procedures are not established which of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

Laboratory controls do not 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.

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.

Strict control is not exercised over labeling issued for use in drug product labeling operations.

The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.

There is a 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 has been already distributed.