1Validation and qualification
Deficiencies in shipping validation.
Inspection Record
Allergan Pharmaceuticals Ireland Unlimited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are inadequate regarding the system for monitoring environmental conditions.
3Aseptic processing and sterility assurance
Cleaning validation has not been conducted for indirect product contact parts used in the fi lling( or (4) For example, the manual cleaning processes for the( D) (4} Itweezers and gaskets that are used in the filling(D) (4) which come into indirect contact with sterile components before filling have not been validated.
4Material and supplier control
Your examination and testing of samples did not assure that the drug product and in-process material conformed to specifications.
5Laboratory and QC controls
The establishment of laboratory test procedures are inadequate.
About this record
Extracted automatically from the document US FDA published on 2026-05-01. 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.
