embecta Medical II LLC – FDA Inspection, Jun 3, 2026

Record Details

This FDA Inspection record concerns embecta Medical II LLC, with an inspection on June 3, 2026, issued by the New Jersey District Office, covering medical devices & rad health.

Company: embecta Medical II LLC
Inspection Date: June 3, 2026
Product Type: Medical Devices & Rad Health
Office: New Jersey District Office
Person: Jaro P. Perera (Issuing Officer)

View Company Profile

ID · e9294d31-b8da-4a4c-b2ed-212a1981d3e5

Inspection Facts

Inspection number: 1320324
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 803.50(a)(2)Individual Report of Malfunction
ISO 13485:2016 Clause 4.1.5Control over outsourced processes not proportionate to risk
ISO 13485:2016 Clause 7.3.7Design and development validation not complete prior to release of product
ISO 13485:2016 Clause 8.2.1Information gathered in feedback process not used as input into risk management
ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements

Full citation text and observation details available on the Dashboard.

Discuss this record with AI

KeyPedia

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore embecta Medical II LLC

FDA Inspection

embecta Medical II LLCJune 3, 2026