1Other quality system
As part of your Master Corrective action plan established to test minerals under LIR commitment only 4 of 5 corrective actions were implemented.
Inspection Record
Wyeth Pharmaceutical,Div Wyeth Holding Corp — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
In the packaging area, failure to demonstrate all requirements were met.
3Other quality system
Failure to use an appropriate scientifically valid method to test the seal over plastic bottles to ensure uniformity of the sealing process across all plastic bottles.
4Equipment and facility
Your hand washing facility does not dispense water at a suitable temperature.
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.
