1Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing areas had difficult to clean and particle-generating equipment or surface.
Inspection Record
Intrathecal Compounding Specialists, LLC — FDA 483 Findings
Inspectors Claire M MindenThe 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
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was found to be present in the ISO 5 classified aseptic processing area during aseptic production.
3Other quality system
Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were insufficient to achieve adequate levels of disinfection.
4Aseptic processing and sterility assurance
Personnel touched equipment or other surfaces located outside of the .ISO 5 classified aseptic processing area with gloved hands and then engaged in aseptic processing without changing or sanitizing gloves .
5Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed leaving and re-entering the cleanroom from non- classified areas without first replacing gowning apparel.
6Other quality system
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7Aseptic processing and sterility assurance
Equipment was and Materials or supplies were not disinfected prior to entering the aseptic processing areas.
8Aseptic processing and sterility assurance
Post filtration integrity testing to the sterilizing filter was not performed.
9Other quality system
You have no assurance that the endotoxin level of your intrathecal drug products are safe, since you do not have any cndotoxin data and your finn doesn't perform endotoxin testing for the finished product.
10Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
11Validation and qualification
lS0-5 classified areas were not certified under dynamic conditions.
12Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed with exposed hair and exposed mouth.
13Contamination control
You produced highly potent drugs without providing adequate segregation, cleaning of work surfaces and cleaning of personnel to prevent cross-contamination.
14Contamination control
Non-microbial contamination was observed in your production area.
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.
