Beekley Corporation FDA Inspections, 483s & Warning Letters (FEI 3000204334)

What FDA found at this site

Latest inspection: Apr 9, 2025: No Action Indicated (NAI)
Inspections on record: 5 (2 VAI, 3 NAI)
Last OAI inspection: None on record
Warning letters: 1 listed by FDA for this FEI, latest Jun 11, 2012
Recalls as the recalling firm: 5, latest Jun 13, 2018

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.

Date	Result	What FDA cited
Apr 9, 2025	No Action Indicated (NAI)	No citations listed
Sep 19, 2018	No Action Indicated (NAI)	Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50)
Apr 28, 2015	Voluntary Action Indicated (VAI)	Design validation - simulated testing (21 CFR 820.30(g))
Nov 16, 2012	Voluntary Action Indicated (VAI)	No citations listed
May 3, 2012	No Action Indicated (NAI)	Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i)) Lack of or inadequate final acceptance procedures (21 CFR 820.80(d)) Investigation of device failures (21 CFR 820.198(c)) Design validation - simulated testing (21 CFR 820.30(g)) and 4 more

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.

Date	Class	Recall	Product and reason
Jun 13, 2018	Class II	Z-2830-2018	O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography. and 2 more products There is a potential for imaging artifact to mimic calcifications on patient's mammograms
May 8, 2017	Class III	Z-2309-2017	Beekley Medical 0-SPOT Mammography Skin Markers REF 652 Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels
Jun 19, 2013	Class III	Z-1787-2014	Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage… Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots
Jul 9, 2012	Class II	Z-2109-2012	Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin… and 3 more products Digital Skin Mammography Marker separating from the backing of the spot material
Jul 2, 2012	Class II	Z-2080-2012	Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product… Imaging artifact can occur on mammogram result

FDA record score

1 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 14, 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.

6 records behind this number

Record	Date	Points x age weight	Adds
Class II recall Z-2830-2018, this FEI as the recalling firm	Jun 13, 2018	4 x 0.25	1
Inspection classified VAI	Apr 28, 2015	10 years or older, so it adds no points	0
Inspection classified VAI	Nov 16, 2012	10 years or older, so it adds no points	0
Class II recall Z-2109-2012, this FEI as the recalling firm	Jul 9, 2012	10 years or older, so it adds no points	0
Class II recall Z-2080-2012, this FEI as the recalling firm	Jul 2, 2012	10 years or older, so it adds no points	0
Warning letter on FDA's dashboard, which does not show close-outs	Jun 11, 2012	10 years or older, so it adds no points	0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
Records	Last refreshed	Source as of	Status
Inspections	Nov 14, 2026	Newest record Nov 5, 2026	Current
Inspection citations	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions (warning letters, injunctions and other action types)	Nov 2, 2026	Newest record Oct 29, 2026	Current
Warning letter text	Nov 14, 2026	Newest record Nov 10, 2026	Current
Recalls (Enforcement Report)	Nov 14, 2026	Newest record Nov 11, 2026	Current
Form 483s and inspection documents	Nov 13, 2026	Newest record Nov 12, 2026	Current
Import refusals	Nov 2, 2026	Newest record Oct 22, 2026	Current

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Facility details

Company: Beekley Corporation
Location: Bristol, CT (US)
Source: device

Beekley Corporation FDA Inspection Record