1Aseptic processing and sterility assurance
On 11/19/2019, I noted turbidity and/or precipitate in the following sterility samples: A.
Inspection Record
Nanobots Healthcare, LLC dba Assurance Infusion — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Media fills are 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
On 11/15/19, during the aseptic processing of Morphine 5mg/ml for Injection, lot #11132019@16, an operator was observed placing his gloved hands outside the ISO 5 area to retrieve supplies.
4Other quality system
Your integrity testing device (Manufacturer: <Redacted B4> has not been calibrated since 2015.
5Aseptic processing and sterility assurance
Your firm uses an <Redacted B4> for the depyrogenation of glassware used in the production of sterile, injectable drug products.
6Aseptic processing and sterility assurance
The wipers placed on the work surface inside the ISO 5 hood during production are not sterile.
7Validation and qualification
The ISO 5 classified area was not certified under dynamic conditions.
8Other quality system
Your firm does not test any lots of intrathecal drug products for endotoxin Qrior to release.
9Aseptic processing and sterility assurance
Your firm does not have sterility testing data to support an assigned BUD ofup to 90 days for intrathecal stock solutions.
About this record
Extracted automatically from the document US FDA published on 2020-02-24. 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.
