FDA Inspection
Pacon Manufacturing CorporationPacon Manufacturing Corporation – FDA Inspection, Jun 20, 2017
Record Details
This FDA Inspection record concerns Pacon Manufacturing Corporation, with an inspection on June 20, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f6efe85d-32e5-45d4-8939-3483aa11f0cf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014922
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR content
- 21 CFR 820.50(b)Supplier notification of changes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pacon Manufacturing Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 20, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 24, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 7, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pacon Manufacturing Corporation
- FDA Inspection 1120832 - 2020-03-13
- FDA Inspection 974407 - 2016-04-20
- FDA Inspection 804886 - 2012-10-24
- FDA Inspection 637289 - 2010-01-07
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