1Aseptic processing and sterility assurance
Your firm failed to provide data to demonstrate that the depyrogenation of glass vials and closures used in the compounding of sterile preparations has been conducted.
Inspection Record
Weatherford Compounding Pharmacy LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Your firm failed to conduct investigations of potency failures for the following compounded sterile preparations: A.
3Aseptic processing and sterility assurance
Documentation was not provided to demonstrate that your firm has conducted <Redacted b4> after compounding of sterile preparations has been performed.
4Aseptic processing and sterility assurance
Your fir m failed to calibrate the <Redacted b4> scale (Manufacturer: <Redacted b4> used in the weighing of raw materials and active pharmaceutical ingredients which are included in compounded sterile preparations.
5Aseptic processing and sterility assurance
Documentation was not provided to demonstrate that your firm bas conducted media fills to validate the sterilization process for compounded sterile preparations (CSP's) for parenteral use.
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.
