Inspection Record

Fagron Compounding Services, LLC — FDA 483 Findings

US FDAInspected 2024-06-28Published 2024-09-26 7 findingsDeviation, CAPA, and investigationLabeling and packagingQuality unit oversightLaboratory and QC controlsAseptic processing and sterility assuranceComplaint and recall handling

Inspectors Taichun QinThe inspectors who signed the published document.Inspector lookup

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

Findings

1Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

2Labeling and packaging

The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(IO)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

3Quality unit oversight

The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products.

4Laboratory and QC controls

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

5Aseptic processing and sterility assurance

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

6Complaint and recall handling

Complaint records are deficient in that they do not include the findings of the investigation and follow-up.

7Labeling and packaging

The container of your outsourcing facility's drug products does not include information required by section 503B(a)(IO)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

About this record

Extracted automatically from the document US FDA published on 2024-09-26. 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

2025-08-08 · US FDA · 6 findings2022-03-24 · US FDA · 6 findings
Fagron Compounding Services, LLC company profile — full history US FDA documents, 2024 Go to Findings search