FDA Inspection
Merlyn Associates, IncMerlyn Associates, Inc – FDA Inspection, Sep 25, 2015
Record Details
This FDA Inspection record concerns Merlyn Associates, Inc, with an inspection on September 25, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Merlyn Associates, Inc
- Inspection Date
- September 25, 2015
- Product Type
- Devices
View Company Profile
ID · a5d73e3b-5012-45b2-8c57-4e2406d43e57
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 945367
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Merlyn Associates, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 1, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 10, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Merlyn Associates, Inc
- FDA Inspection 1082189 - 2019-03-01
- FDA Inspection 835099 - 2013-05-10
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