INTEGRATED MEDCRAFT LLC — FDA Facility Profile
INTEGRATED MEDCRAFT LLC is an FDA-registered facility (FEI 3030078769) located in East Hampton, CT, US. RegDataLab tracks 1 FDA inspection at this facility.
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What FDA found at this site
- Latest inspection
- Apr 8, 2026: No Action Indicated (NAI)
- Inspections on record
- 1 (1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 2, latest Sep 25, 2026
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 8, 2026 | No Action Indicated (NAI) | Corrective action procedures not documented (ISO 13485:2016 Clause 8.5.2) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Sep 25, 2026 | Not yet classified | Z-0147-2027 | FORWARD Gunshot Wound Kit;
Model: AFT-GSW; Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad… |
| Jul 7, 2026 | Not yet classified | Z-2836-2026 | FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002… and 1 more product Devices could potentially contain an occluded or partially occluded Guedel Airway tip. |
Facility details
- Company
- INTEGRATED MEDCRAFT LLC
- Location
- East Hampton, CT (US)
- Source
- device