Inspection Record

PharMEDium Services LLC — FDA 483 Findings

US FDAInspected 2016-07-05Published 2024-01-17 8 findingsLaboratory and QC controlsAseptic processing and sterility assuranceLabeling and packagingQuality unit oversight

Inspectors Barbara J Wilimczyk-Macri · Nicholas A Violand · Mina AhmadiThe 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

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.

2Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

3Aseptic processing and sterility assurance

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

4Labeling and packaging

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

5Aseptic 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.

6Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.

7Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be steril e are not written and followed.

8Quality unit oversight

Each lot of components and drug product containers is not withheld from use until the lot had been sampled, tested, examined, and released by the quality control unit.

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

2016-04-18 · 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 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