FDA Inspection
Modern Surgical Instruments LLCModern Surgical Instruments LLC – FDA Inspection, Oct 24, 2019
Record Details
This FDA Inspection record concerns Modern Surgical Instruments LLC, with an inspection on October 24, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 24, 2019
- Product Type
- Devices
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ID · 6fdbd58b-340f-4613-9eee-8aa98fb23865
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1107512
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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