FDA Inspection
Paradigm Packaging West, LLCParadigm Packaging West, LLC – FDA Inspection, Aug 13, 2026
Record Details
This FDA Inspection record concerns Paradigm Packaging West, LLC, with an inspection on August 13, 2026, issued by the Los Angeles District Office, covering medical devices & rad health.
- Company
- Paradigm Packaging West, LLC
- Inspection Date
- August 13, 2026
- Product Type
- Medical Devices & Rad Health
- Person
View Company Profile
ID · dfc59f12-5489-4793-a9ff-c6d2f726f6f2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1336052
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- ISO 13485:2016 Clause 7.4.1Criteria for the evaluation and selection of suppliers not established
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
- ISO 13485:2016 Clause 8.3.1Nonconforming product not identified and controlled
- ISO 13485:2016 Clause 8.4Procedures for analysis of data not documented
- ISO 13485:2016 Clause 8.4Procedures for data analysis do not include determination of appropriate methods
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Paradigm Packaging West, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 28, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 13, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 29, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Paradigm Packaging West, LLC
- FDA Inspection 1116117 - 2020-01-28
- FDA Inspection 989542 - 2016-07-13
- FDA Inspection 732301 - 2011-06-29
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.