1Other quality system
There is no established written procedure in the event ofchange in the version ofthe Certificate ofAnalysis.
Inspection Record
Gadea Biopharma S.L. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Original records of analysis submitted in the drug application was not available.
3Equipment and facility
Labeling equipment is not qualified in preparation for commercialization ofdrug product.
4Labeling and packaging
There are no established written procedures for handling labeling and packing operations.
5Other quality system
The Certificate of Analysis from the drug application does not match the raw data from the analytical test records and specification sheet.
6Other quality system
The information stated in the submitted drug application is not exactly as is on site.
About this record
Extracted automatically from the document US FDA published on 2018-12-04. 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.
