Inspection Record

PharMEDium Services LLC — FDA 483 Findings

US FDAInspected 2015-07-10Published 2024-01-17 7 findingsLaboratory and QC controlsAseptic processing and sterility assuranceStability and storageOther quality systemComplaint and recall handlingTraining and personnel

Inspectors Russell GlapionThe inspectors who signed the published document.Inspector lookup

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

Findings

1Laboratory and QC controls

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.

2Aseptic processing and sterility assurance

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

3Stability and storage

An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.

4Other quality system

Written procedures are lacking which describe in sufficient detail the receipt, identification, sampling, testing, and approval of closures.

5Complaint and recall handling

Written records of investigation of a drug complaint do not include the findings of the investigation.

6Aseptic processing and sterility assurance

Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.

7Training and personnel

Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.

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 findings2015-11-12 · US FDA · 7 findings2015-09-21 · US FDA · 9 findings2015-10-05 · US FDA · 8 findings
PharMEDium Services LLC findings history — including this company's other documents US FDA documents, 2024 Go to Findings search