Inspection Record

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

US FDAPublished 2024-01-17 3 findingsAseptic processing and sterility assuranceOther quality systemEquipment and facility

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

Findings

1Aseptic processing and sterility assurance

Your firm uses a <Redacted B4> for the depyrogenation of glassware used in the production of sterile, injectable drug products.

2Other quality system

Your firm does not test all lots of intrathecal drug products for endotoxin prior to release.

3Equipment and facility

On 6/27/18, I observed that the magnahelic gauge monitoring differential pressure between the ISO 8 anteroom and unclassified area was at "O".

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.

Other records for this company

2018-07-20 · US FDA · 4 findings2019-07-24 · US FDA · 3 findings
People’s Custom Rx and Clinical Care, LLC findings history — including this company's other documents US FDA documents, 2024 Go to Findings search