FDA Inspection
Burpee Materials Technology, LLCBurpee Materials Technology, LLC – FDA Inspection, Dec 12, 2018
Record Details
This FDA Inspection record concerns Burpee Materials Technology, LLC, with an inspection on December 12, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Li Li (Issuing Officer)
View Company Profile
ID · 8863668a-3797-4389-92a1-49be9c4d4aab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1079300
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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Other FDA inspections of Burpee Materials Technology, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2026 | Not classified | New Jersey District Office | |
| August 8, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 14, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 16, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Burpee Materials Technology, LLC
- FDA Inspection 1321152 - 2026-05-18
- FDA Inspection 1211612 - 2023-08-08
- FDA Inspection 1045858 - 2018-03-14
- FDA Inspection 919912 - 2015-03-16
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