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KDC/ONE Development Corporation, Inc — FDA Facility Profile

FEI 3003690512

KDC/ONE Development Corporation, Inc is an FDA-registered facility (FEI 3003690512) located in Knowlton, CA. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 5 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jan 27, 2023: Voluntary Action Indicated (VAI)
Inspections on record
5 (2 VAI, 3 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
1, latest Nov 22, 2016
Import refusals
10 or more

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
Jan 27, 2023Voluntary Action Indicated (VAI)Procedure Deviations Recorded and Justified (21 CFR 211.100(b))
Signatures and dates--person who performs test (21 CFR 211.194(a)(7))
Sep 21, 2017Voluntary Action Indicated (VAI)No citations listed
Oct 31, 2014No Action Indicated (NAI)No citations listed
Dec 6, 2012No Action Indicated (NAI)No citations listed
Aug 12, 2009No Action Indicated (NAI)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 22, 2016Class IIID-0225-2017Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed by: Tom's of…
Labeling: Label Mix Up- Incorrect back label applied to the product.

Facility details

Company
KDC/ONE Development Corporation, Inc.
Location
Knowlton (CA)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

Import refusals

FDA data resources

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