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ROCKET MEDICAL PLC FDA Inspection Record

FEI 3002808026 · Inspections, Form 483s, warning letters and import refusals

ROCKET MEDICAL PLC is an FDA-registered facility (FEI 3002808026) located in WASHINGTON Sunderland, GB. RegDataLab tracks 1 FDA inspection and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Jul 14, 2011: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
Jul 14, 2011
Warning letters
1 listed by FDA for this FEI, latest Oct 13, 2011
Recalls as the recalling firm
2, latest Nov 7, 2025
Import refusals
2

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Jul 14, 2011Official Action Indicated (OAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Nov 7, 2025Class IIZ-0950-2026Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure… and 5 more products
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out…
Aug 1, 2019Class IIZ-0512-2020Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
A complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used. In addition, the company…

FDA record score

5 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

4 records behind this number
RecordDatePoints x age weightAdds
Class II recall Z-0950-2026, this FEI as the recalling firmNov 7, 20254 x 14
Class II recall Z-0512-2020, this FEI as the recalling firmAug 1, 20194 x 0.251
Warning letter on FDA's dashboard, which does not show close-outsOct 13, 201110 years or older, so it adds no points0
Inspection classified OAIJul 14, 201110 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Rocket Medical Plc
Location
WASHINGTON Sunderland (GB)
Source
device

Compliance actions

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.