Company
United Statesembecta Medical II LLC, Parsippany, NJ – FDA Inspections
Inspection records and compliance data for embecta Medical II LLC in Parsippany, NJ. 1 FDA inspection on record, 1 Form 483, last inspected June 03, 2026.
Company Profile
This profile covers embecta Medical II LLC based in Parsippany, NJ, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected June 3, 2026.
Most cited issue areas
- Complaint handling procedures lack required elements1 inspection
- Control over outsourced processes not proportionate to risk1 inspection
- Design and development validation not complete prior to release of product1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 3, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1320324 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
embecta Medical II LLC
FEI Number
3022699058
Address
300 Kimball Dr Ste 300, Parsippany, NJ 07054-2184, United States
Country
United States
ID: a567ee0f-7078-4c02-bd3c-f6e7c0816bc9