Inspection Record

Professional Disposables International, Inc. — FDA 483 Findings

US FDAInspected 2015-07-11Published 2024-01-17 3 findingsOther quality systemDeviation, CAPA, and investigationProcess validation

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Findings

1Other quality system

Procedures describing the warehousing of drug products are not established and followed Specifically, the firm failed to follow the section 7.9.1.3" (b)(4) (b)(4) * DATES OF INSPECTION: IOIl4 /20 10(Thu), IO/1 5/201 0(Fri), IO/1 912 010(Tue), IO/21 /2010(Thu) EMPLO YEEIS ) SIG NA...

2Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed .

3Process validation

Written production and process control procedures are not followed in the exec ution of production and process control functions.

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

2015-07-11 · US FDA · 3 findings2015-07-11 · US FDA · 4 findings2023-12-12 · Health Canada · 4 findings
Professional Disposables International, Inc. company profile — full history US FDA documents, 2024 Go to Findings search