1Equipment and facility
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations.
Inspection Record
Qualgen LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design or suitably located to facilitate operations for its cleaning and maintenance.
3Documentation and records
The master production and control records are deficient in that they do not include complete manufacturing and control instructions and procedures.
4Labeling and packaging
The containers of your outsourcing facility's drug products does not include information required by section 503B (a)(l0)(B).
5Aseptic processing and sterility assurance
Drug product closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
6Equipment and facility
Routine calibration of automatic, mechanical, and electronic equipment is not performed according to a written program designed to assure proper performance.
7Labeling and packaging
The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(l 0) (A).
About this record
Extracted automatically from the document US FDA published on 2022-05-05. 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.
