Firm Record
PharMEDium Services, LLC findings history
133 findings from 15 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Aseptic processing and sterility assuranceLaboratory and QC controlsEquipment and facilityOther quality systemLabeling and packagingDeviation, CAPA, and investigationStability and storageQuality unit oversightProcess validationTraining and personnelDocumentation and recordsComplaint and recall handlingContamination controlMaterial and supplier controlComputer system validation
Published inspection documents
2024-01-17
US FDA
8 findingsLaboratory and QC controls · Aseptic processing and sterility assurance · Labeling and packaging · Quality unit oversight Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
2024-01-17
US FDA
6 findingsLaboratory and QC controls · Stability and storage · Aseptic processing and sterility assurance · Other quality system · Deviation, CAPA, and investigation Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
2024-01-17
US FDA
5 findingsAseptic processing and sterility assurance · Stability and storage The firm does not maintain reserve samples for any sterile drug products manufactured and distributed.
2024-01-17
US FDA
7 findingsAseptic processing and sterility assurance · Laboratory and QC controls · Documentation and records · Equipment and facility Aseptic processing areas arc deficient regarding the system for cleaning and disinfecting the room and equipment to produce asepuc condit•ons.
2024-01-17
US FDA
9 findingsOther quality system · Contamination control · Labeling and packaging · Laboratory and QC controls · Training and personnel · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility · Documentation and records Employees engaged in the manufacture, processing.
2024-01-17
US FDA
8 findingsAseptic processing and sterility assurance · Stability and storage · Process validation · Labeling and packaging · Deviation, CAPA, and investigation · Laboratory and QC controls Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
2024-01-17
US FDA
11 findingsAseptic processing and sterility assurance · Computer system validation · Laboratory and QC controls · Material and supplier control · Labeling and packaging · Equipment and facility Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
2024-01-17
US FDA
12 findingsMaterial and supplier control · Laboratory and QC controls · Aseptic processing and sterility assurance · Labeling and packaging · Equipment and facility · Process validation · Quality unit oversight Certificates of testing of containers and closures are accepted in lieu of testing without establishing the reliability of the supplier's test results through appropriate validation of the test results at appropriate intervals.
2024-01-17
US FDA
7 findingsLaboratory and QC controls · Aseptic processing and sterility assurance · Stability and storage · Other quality system · Complaint and recall handling · Training and personnel Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
2024-01-17
US FDA
13 findingsEquipment and facility · Process validation · Aseptic processing and sterility assurance · Laboratory and QC controls · Contamination control · Other quality system Equipment used in the manufacture, processing, packing or holding ofdrug products is not suitably located to facilitate operations for its intended use.
2024-01-17
US FDA
6 findingsEquipment and facility · Training and personnel · Deviation, CAPA, and investigation · Documentation and records · Quality unit oversight Suitable reader or photocopying equipment was not made readily available for drug product records maintained using reduction techniques.
2024-01-17
US FDA
10 findingsAseptic processing and sterility assurance · Laboratory and QC controls · Deviation, CAPA, and investigation · Other quality system · Quality unit oversight Procedures designed to prevent microbiological contamination of sterile drug products does not include adequate validation of aseptic processing.
2024-01-17
US FDA
12 findingsLaboratory and QC controls · Process validation · Contamination control · Deviation, CAPA, and investigation · Other quality system · Labeling and packaging · Complaint and recall handling · Aseptic processing and sterility assurance · Documentation and records · Equipment and facility 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.
2024-01-17
US FDA
13 findingsTraining and personnel · Quality unit oversight · Stability and storage · Labeling and packaging · Material and supplier control · Complaint and recall handling · Deviation, CAPA, and investigation · Equipment and facility · Other quality system · Aseptic processing and sterility assurance Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.
2024-01-17
US FDA
6 findingsAseptic processing and sterility assurance · Laboratory and QC controls · Labeling and packaging · Other quality system · Equipment and facility Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
About this page
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.
What is included. As of 2026-09-03, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.
Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.
