FDA Inspection
Electronic Manufacturing Services Group, IncElectronic Manufacturing Services Group, Inc – FDA Inspection, Jan 26, 2018
Record Details
This FDA Inspection record concerns Electronic Manufacturing Services Group, Inc, with an inspection on January 26, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 26, 2018
- Product Type
- Devices
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ID · 708f972c-279a-4a7b-a3ab-6a51057ba36a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1038889
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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Other FDA inspections of Electronic Manufacturing Services Group, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 8, 2024 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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