FDA Inspection
Lowell, Inc.Lowell, Inc. – FDA Inspection, Mar 10, 2017
Record Details
This FDA Inspection record concerns Lowell, Inc., with an inspection on March 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ff2c81fb-9a51-4e1b-b44f-b2bf32fc1daa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1004052
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Lowell, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 8, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Lowell, Inc.
- FDA Inspection 1194244 - 2022-12-06
- FDA Inspection 729519 - 2011-06-08
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