Wells Pharma of Houston LLC — FDA 483 Findings

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.

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

The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(I0)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

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

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.