Inspection Record

PharMEDium Services, LLC — FDA 483 Findings

US FDAInspected 2015-11-12Published 2024-01-17 7 findingsAseptic processing and sterility assuranceLaboratory and QC controlsDocumentation and recordsEquipment and facility

Inspectors Camerson E. Moore · Jason R. Caballero · Stephen D. BrownThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Aseptic processing and sterility assurance

Aseptic processing areas arc deficient regarding the system for cleaning and disinfecting the room and equipment to produce asepuc condit•ons.

2Laboratory and QC controls

Testing and release of drug product for distribution do not include app ropriate laboratory determination ofsatisfactory conformance to the identity and strength of each active ingred ient prior to release.

3Documentation and records

The batch production and control records are deficient in that they do not include specimen and copy of labeling.

4Laboratory and QC controls

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

5Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not followed.

6Equipment and facility

The labels of your ou tsou rcing facility's drug products are deficient.

7Aseptic processing and sterility assurance

Each batch or drug product purporting to be sterile and pyrogen-free is not laboratory tested 10 determine conformance to such requ irements.

About this record

Extracted automatically from the document US FDA published on 2024-01-17. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

Other records for this company

2016-07-05 · US FDA · 8 findings2016-04-18 · US FDA · 6 findings2015-11-03 · US FDA · 5 findings2015-09-21 · US FDA · 9 findings2015-10-05 · US FDA · 8 findings2015-09-11 · US FDA · 11 findings
PharMEDium Services, LLC findings history — including this company's other documents US FDA documents, 2024 Go to Findings search