1Complaint and recall handling
Procedures for handling complaints were not followed.
Inspection Record
Pacifico National Inc. dba Amex Pharmacy — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Documentation and records
Batch records for re-packaged Avastin do not provide complete documentation of production off each batch of d rug product.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
4Labeling and packaging
The labels of your outsourcing facility's drug products do not include information required by section 503B(a) (10)(A)&(B).
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and e quipment to produce aseptic conditions.
6Stability and storage
Results of stability testing are not used in determining expiration dates.
7Documentation and records
Your outsourcing facility was unable to identify which batch of Avastin was dispensed to each patient due to specimens of patient-specific labels not being maintained within the batch record.
8Quality unit oversight
Procedures describing the role and responsibilities of the quality control unit have not been adequately established and followed.
9Other quality system
Your firm failed to establish and follow an Out of Specification (OOS) Procedure.
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.
