1Other quality system
(Repeat Observation) The ISO-5 classified area is located within a non-classified room (segregated compounding area).
Inspection Record
Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy — FDA 483 Findings
Inspectors Helen Verdel · Janet A. RajanThe 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
(Repeat Observation) Media fills were not performed that closely simulate aseptic compounding operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.
3Validation and qualification
(Repeat Observation) 1SO-5 classified areas were not certified under dynamic conditions.
4Equipment and facility
Vermin was observed present in areas immediately adjacent to your compounding area.
5Aseptic processing and sterility assurance
4 The final containers/closures used for drug products intended to be sterile were not maintained to ensure that drug products intended to be sterile maintain sterility.
6Contamination control
Non-microbial contamination was observed in your compounding area.
7Contamination control
Your firm compounded drugs while construction was underway in an adjacent area without adequate controls to prevent contamination of the compounding environment and product.
About this record
Extracted automatically from the document US FDA published on 2021-12-30. 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.
