PharMEDium Services, LLC. – FDA 483, Jan 5, 2018

This FDA Form 483 documents multiple deficiencies at an outsourcing facility, indicating significant issues with sterile drug product manufacturing and quality control.

Key observations include: * **Microbiological Control:** Lack of established, written, and followed procedures to prevent microbiological contamination of sterile drug products. * **Process Validation:** Absence of control procedures to validate manufacturing processes affecting in-process material and drug product characteristics. * **Equipment Maintenance:** Failure to maintain equipment and utensils at appropriate intervals to prevent contamination. * **Aseptic Processing Deficiencies:** * Inadequate environmental monitoring systems. * Deficient systems for maintaining equipment used to control aseptic conditions. * Inadequate cleaning and disinfecting procedures for rooms and equipment. * **Air Filtration:** The production area air supply lacks an appropriate air filtration system. * **Sampling:** Samples taken for conformance testing are not representative. * **Deviation Management:** Failure to thoroughly review unexplained discrepancies, even for distributed batches. * **Production & Process Controls:** No written procedures to assure drug product identity, strength, quality, and purity. * **Filtration Validation:** Unvalidated use of a (b)(4) for particulate removal during the (b)(4) process, with no compatibility determination or documentation in batch records. * **Container/Closure Issues:** * Containers and closures not tested per written procedures. * Container