Inspection Record

JCB Laboratories LLC — FDA 483 Findings

US FDAInspected 2016-02-23Published 2024-01-17 5 findingsLaboratory and QC controlsDocumentation and recordsMaterial and supplier controlAseptic processing and sterility assuranceLabeling and packaging

Inspectors Carl A Huffman · Brett R HavranekThe 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 drug products conform to appropriate standards of identity, strength, quality and purity.

2Documentation and records

The master production and control records are deficient in that they do not include complete manufacturing and instructions and testing.

3Material and supplier control

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

4Aseptic processing and sterility assurance

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

5Labeling and packaging

The container labels ofyour outsourcing facility?s drug products are deficient.

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

2018-09-14 · US FDA · 8 findings
JCB Laboratories LLC company profile — full history US FDA documents, 2024 Go to Findings search