Inspection Record

People’s Custom Rx and Clinical Care, LLC — FDA 483 Findings

US FDAInspected 2019-07-24Published 2019-10-01 3 findingsContamination controlAseptic processing and sterility assurance

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

Findings

1Contamination control

Your firm produced highly potent drugs without providing adequate cleaning of work surfaces to prevent cross ­contamination.

2Aseptic processing and sterility assurance

The cleaning wipes used in the lSO 5 classified aseptic processing areas were not sterile.

3Aseptic processing and sterility assurance

Review of the certification report for the cleanrooms dated 3/28/19 revealed that smoke studies in the ISO 5 hood were not performed under dynamic conditions.

About this record

Extracted automatically from the document US FDA published on 2019-10-01. 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

2024-01-17 · US FDA · 3 findings2018-07-20 · US FDA · 4 findings
People’s Custom Rx and Clinical Care, LLC findings history — including this company's other documents US FDA documents, 2019 Go to Findings search