FDA Inspection
Perma Pure LLCPerma Pure LLC – FDA Inspection, Aug 23, 2010
Record Details
This FDA Inspection record concerns Perma Pure LLC, with an inspection on August 23, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Perma Pure LLC
- Inspection Date
- August 23, 2010
- Product Type
- Devices
View Company Profile
ID · de0be5b0-626d-43ff-b9a6-f39ad8f8b1e4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 675749
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.80(e)Documentation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.70(i)Documentation of software validation
Showing 10 of 12 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Perma Pure LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2026 | NAI | Compliance: Devices | |
| January 3, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 21, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 9, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 19, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Perma Pure LLC
- FDA Inspection 1309030 - 2026-03-06
- FDA Inspection 1115239 - 2020-01-03
- FDA Inspection 956470 - 2016-01-21
- FDA Inspection 838041 - 2013-07-09
- FDA Inspection 745531 - 2011-09-19
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.