Inspection Record

Professional Disposables International, Inc. — FDA 483 Findings

US FDAInspected 2015-07-11Published 2024-01-17 3 findingsComplaint and recall handlingOther quality systemLaboratory and QC controls

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

Findings

1Complaint and recall handling

Procedures describing the handling of all WTitten and oral complaints regarding a drug product are not followed.

2Other quality system

Procedures describing the warehousing of drug products are not established and followed .

3Laboratory and QC controls

Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy and completeness.

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