1Other quality system
In regard to the production of highly potent drugs: A.
Inspection Record
Vita Pharmacy, LLC dba Talon Pharmacy of Boerne — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Cleaning validation
On 1/24/20, 1 (Stephen Brown) observed brownish residue on a corner of the HEPA filter located in the ISO 5 workbench area.
3Aseptic processing and sterility assurance
The glass beakers used in the production of sterile, injectable drug products are not depyrogenated prior to use.
4Environmental monitoring
Your firm does not perform environmental monitoring of the <Redacted B4>
5Aseptic processing and sterility assurance
In regard to aseptic practice: A.
6Environmental monitoring
In regard to the latest clean room certification dated 10/3/19: A.
About this record
Extracted automatically from the document US FDA published on 2020-03-09. 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.
