1Other quality system
The system used to manage changes to formulations and processes is not always effective.
Inspection Record
Wedgewood Village Pharmacy, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Documentation and records
The following deficiencies were observed during review of compounding batch log sheets (batch records): A) There is no traceability ofsterile components used throughout the compounding process, such as sterile tubing
3Aseptic processing and sterility assurance
Sterile veterinary compounds are not routinely tested for sterility and endotoxin limit, regardless of quantity produced or method or preparation.
4Aseptic processing and sterility assurance
Steps to control routine bioburden in raw mateials and/or components to be used in REDACTED (b)(4) sterilized p roducts are not always taken.
5Aseptic processing and sterility assurance
Raw materials sucb as bulk active ingredients are not routinely tested for identity, and raw materials being used in sterile compounded drugs are not evaluated for routine bioburden.
6Complaint and recall handling
Reports ofadverse events and complaints relating to potential quality or labeling defects are not trended and evaluated for possible systemic issues that could affect more than one product.
7Material and supplier control
Efforts to prevent cross contamination ofallergens such as cephalosporins and potent materials such as hormones have not been evaluated for effectiveness.
8Aseptic processing and sterility assurance
There is a lack ofassurance ofsterility for compounded sterile human and veterinary drugs, including injectable, implantable and ophthalmic products.
9Other quality system
There is no assurance that testing performed by contract laboratories on finished compounded drugs is adequately and appropriately performed.
10Aseptic processing and sterility assurance
Sterile human compounds are not always tested for sterility, even when made from non-sterile ingredients.
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.
