FDA Inspection
Lynn Medical Instrument Co.Lynn Medical Instrument Co. – FDA Inspection, Jul 31, 2026
Record Details
This FDA Inspection record concerns Lynn Medical Instrument Co., with an inspection on July 31, 2026, issued by the Detroit District Office, covering medical devices & rad health.
- Company
- Lynn Medical Instrument Co.
- Inspection Date
- July 31, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 81b8efe6-e980-4de3-93f8-222210a7f28a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1328776
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued, view the record
FDA Citations
8- 21 CFR 806.20(a)Records not kept
- ISO 13485:2016 Clause 4.1.1QMS not documented and maintained adequately
- ISO 13485:2016 Clause 4.1.6QMS software not validated prior to use or changes
- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.4.1Supplier monitoring and re-evaluation not planned
- ISO 13485:2016 Clause 7.4.3Purchased product verification activities not established or implemented
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
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Other FDA inspections of Lynn Medical Instrument Co.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 27, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 11, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Lynn Medical Instrument Co.
- FDA Inspection 736446 - 2011-07-27
- FDA Inspection 603586 - 2009-08-11
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