FDA Inspection
MODERN MEDICAL SUPPLIES LLCMODERN MEDICAL SUPPLIES LLC – FDA Inspection, Jun 12, 2026
Record Details
This FDA Inspection record concerns MODERN MEDICAL SUPPLIES LLC, with an inspection on June 12, 2026, issued by the San Francisco District Office, covering medical devices & rad health.
- Company
- MODERN MEDICAL SUPPLIES LLC
- Inspection Date
- June 12, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 46b40fdb-ea4b-400b-9a53-8534cf3962db
Inspection Facts
- Inspection number
- 1322302
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
- 21 CFR 820.35(a)Records for complaints involving failure to meet specifications not maintained
- ISO 13485:2016 Clause 4.1.1QMS not documented and maintained adequately
- ISO 13485:2016 Clause 4.1.5Inadequate monitoring and control over outsourced processes
- ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
- ISO 13485:2016 Clause 8.2.4Internal audits not conducted to ensure QMS meets requirements and is effective
- ISO 13485:2016 Clause 8.4Procedures for analysis of data not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MODERN MEDICAL SUPPLIES LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2024 | Not classified | San Francisco District Office | Compliance: Devices |
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