Inspection Record

Brookfield Pharmacy — FDA 483 Findings

US FDAInspected 2017-08-03Published 2024-01-17 5 findingsOther quality systemEquipment and facilityEnvironmental monitoringValidation and qualification

Inspectors Nealie C. Newberger · Dien N. NguyenThe inspectors who signed the published document.Inspector lookup

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

Findings

1Other quality system

continued: for use of REDACT ED (b) (4) stipulate effective contact times o f: REDACTED (b) (4) for bacter ial spores, RE DACTED (b) (4 ) for b acteria and viruses, R EDACTED (b) (4) for fungi, and REDACTED (b) (4) for TB.

2Equipment and facility

The ISO classified areas have difficult to clean, particle-generating, or visibly dirty equipment of surfaces.

3Environmental monitoring

The use of sporicidal agents in the cleanrooms and ISO classified areas are inadequate.

4Validation and qualification

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

5Other quality system

Your firm produces drug products intended for intrathecal use from non-sterile bulk active ingredients that are notcontrolled for endotoxin level.

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.

Brookfield Pharmacy company profile — full history US FDA documents, 2024 Go to Findings search