1Aseptic processing and sterility assurance
The <Redacted B4> intended to render final product sterile was not pharmaceutical grade.
Inspection Record
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Environmental monitoring was inadequately performed in your aseptic processing areas.
3Aseptic processing and sterility assurance
The ISO S classified aseptic processing areas had difficult to clean and visibly dirty equipment or surface.
4Aseptic processing and sterility assurance
You had inadequate HEPA filter coverage and air/low over the area to which sterile product was exposed.
5Material and supplier control
You used a non-pharmaceutical grade component in the formulation of a drug product.
6Contamination control
You produced hazardous drugs without providing adequate cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.
7Aseptic processing and sterility assurance
Materials or supplies were not disinfected prior to entering the aseptic processing areas.
8Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed with exposed hair.
9Aseptic 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 Specifically, Media fills conducted on 01/08/2019, • 07/08/2019, and 11/25/2019 are performed using operations consisting of drawing up syringes to produce <Redacted B4> mL vials via <Redacted B4>.
10Aseptic processing and sterility assurance
Your firm failed to conduct adequate cleaning and disinfection in aseptic processing areas.
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.
