Inspection Record

I.V. Specialty Ltd. — FDA 483 Findings

US FDAInspected 2017-09-12Published 2024-01-17 3 findingsValidation and qualificationEnvironmental monitoringAseptic processing and sterility assurance

Inspectors Scott Ballard · Nimmy MathewsThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Validation and qualification

IS0-5 classified areas were not certified under dynamic conditions.

2Environmental monitoring

Cleaning or Sanitizing of ISO 7 clean room is not adequate.

3Aseptic processing and sterility assurance

Sterility Assurance is not adequate Surface samples collected inside the ISO 5 LAF Hood on REDACTED (b) (4) basis are not incubated at REDACTED (b) (4) C per manufacturer instruction.

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.

Other records for this company

2016-09-01 · US FDA · 8 findings
I.V. Specialty Ltd. company profile — full history US FDA documents, 2024 Go to Findings search