PharMEDium Services, LLC. — FDA 483 Findings

Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

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

Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

Containers and closures are not tested for conformance with all appropriate written procedures.

The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10) (A).

Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.

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

Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

Samples taken of drug products for determination of conformance to written specifications are not representative.

The production area air supply Jacks an appropriate air filtration system.