1Other quality system
Drug products failing to meet established specifications are not rejected.
Inspection Record
Qualgen, LLC — FDA 483 Findings
Inspectors Patty P Kaewussdangkul · Margaret M AnnesThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Written procedures are not followed that describe the examinations to be conducted on appropriate samples of in-process materials of each batch.
3Labeling and packaging
The labels of your outsourcing facility's drug products are deficient.
4Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
5Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
6Laboratory 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.
About this record
Extracted automatically from the document US FDA published on 2022-11-28. 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.
