Inspection Record

First Royal Care Co. LLC, dba Red Mountain Compounding — FDA 483 Findings

US FDAInspected 2022-09-12Published 2023-01-30 3 findingsValidation and qualificationEquipment and facilityContamination control

Inspectors Christopher M. JennerThe 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

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

2Equipment and facility

The ISO 5 classified equipment has difficult to clean surfaces.

3Contamination control

Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils and/or personnel to prevent cross-contamination.

About this record

Extracted automatically from the document US FDA published on 2023-01-30. 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

2021-08-11 · US FDA · 15 findings
First Royal Care Co. LLC, dba Red Mountain Compounding company profile — full history US FDA documents, 2023 Go to Findings search