1Other quality system
The firm fai led to adequately evaluate product integrity incident reports, received from patients and healthcare practitioners, for injectable Progesterone produced in various solutions (e.g.
Inspection Record
Village Fertility Pharmacy, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Although the formula worksheets state the API an d raw materials are non-sterile and the vials are sterile, pharma cy technican responsible for mixing and filling all compounded products explained that the vials and stoppers are rec ieved non-sterile.
3Aseptic processing and sterility assurance
Although the formula worksheets state the API and raw materials are non-sterile and the vials are sterile, pharmacy technican responsible for mixing and filling all compounded products explained that the vials and stoppers are recieved non-sterile.
4Other quality system
On 11/23/2012, the firm made Leuprolide 40mcg/0.1 ml, lot K2312-20, 5 ml filled vial s.
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.
