1Aseptic processing and sterility assurance
Stock solutions used in the preparation of sterile finished drug products are not <Redacted B4> sterilized nor stored in sterile containers.
Inspection Record
Stonegate Pharmacy LP — FDA 483 Findings
Inspectors Patty P KaewussdangkulThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Media fills were not performed that closely simulate aseptic production operations incorporating as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.
3Aseptic processing and sterility assurance
<Redacted B4> are not used properly to verify the adequacy of the sterilization <Redacted B4> _______ a) Your firm <Redacted B4> sterilizes vials of Testosterone in <Redacted B4> and <Redacted B4>.
4Training and personnel
Personnel hand washing procedure was c onducted i n a w ay that may have cause the gowning apparel to b ecome contaminated.
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.
