Inspection Record
Inspectors Meredith M. CobbThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Your firm continued producing sterile drug products while construction was ongoing within your facility without establishing adequate controls to prevent contamination of the production environment.
Your firm did not conduct smoke studies of the aseptic processing area under dynamic conditions.
On 07/12/16, dead insects and fungal growth were found in the ISO 7 annex room during cleaning.
Actionable microbial contamination was present in the ISO 5 area or in adjacent areas during aseptic production.
Your firm produced sterile drug products within the REDACTED (b)(4) Clean Room during pressure differential failures on 5/25/16, 5/26/16, 5/27/16, 5/31/16,6/8/16 and 6/9/16.
Hazardous and non-hazardous drugs were produced in the same area without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
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.
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