Inspection Record

PharMEDium Services, LLC. — FDA 483 Findings

US FDAInspected 2015-10-05Published 2024-01-17 8 findingsAseptic processing and sterility assuranceStability and storageProcess validationLabeling and packagingDeviation, CAPA, and investigationLaboratory and QC controls

Inspectors Claire M. MindenThe inspectors who signed the published document.Inspector lookup

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Findings

1Aseptic processing and sterility assurance

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

2Stability and storage

Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.

3Aseptic 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.

4Process validation

There are no written procedures for production and process controls designed to assure that the drug products have the ident ity, strength, quality, and purity they purport or ar e represented to possess.

5Labeling and packaging

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

6Deviation, CAPA, and investigation

I There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

7Aseptic processing and sterility assurance

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

8Laboratory 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.

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.

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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 findings2015-09-11 · US FDA · 11 findings
PharMEDium Services, LLC. findings history — including this company's other documents US FDA documents, 2024 Go to Findings search