Inspection Record

Reliant Compounded Solutions Monroe, LLC — FDA 483 Findings

US FDAInspected 2023-08-23Published 2023-09-22 4 findingsOther quality systemAseptic processing and sterility assuranceTraining and personnel

Inspectors Robert J MartinThe 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

from FDA 2019 Inspection (8/06/2019 -08/29/2019)

2Aseptic processing and sterility assurance

Smoke studies were inadequately performed under dynamic conditions.

3Training and personnel

Personnel were observed moving quickly in a critical area or in an area immediately adjacent to a critical area likely causing disruption of unidirectional airflow.

4Aseptic processing and sterility assurance

Sterile drugs were exposed to lower than ISO 5 quality air.

About this record

Extracted automatically from the document US FDA published on 2023-09-22. 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.

Reliant Compounded Solutions Monroe, LLC company profile — full history US FDA documents, 2023 Go to Findings search