Natures Formulae Health Products Ltd. FDA Inspection Record

FEI 2000027163 · Inspections, Form 483s, warning letters and import refusals

Natures Formulae Health Products Ltd. is an FDA-registered facility (FEI 2000027163) located in Kelowna, CA. Registered operations: MANUFACTURE. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Nov 3, 2023: Voluntary Action Indicated (VAI)
Inspections on record
3 (2 VAI, 1 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
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
Nov 3, 2023Voluntary Action Indicated (VAI)Cleaning SOPs/equipment protection (21 CFR 211.67(b)(5))
Absence of Written Procedures (21 CFR 211.100(a))
Review of representative number of batches (21 CFR 211.180(e)(1))
Active ingredient retained sample kept (21 CFR 211.170(a))
Oct 21, 2016Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
New and Unapproved Cite
Testing and release for distribution (21 CFR 211.165(a))
Microbiological testing (21 CFR 211.165(b))
and 1 more
Feb 13, 2013No Action Indicated (NAI)No citations listed

Facility details

Company
Natures Formulae Health Products Ltd.
Location
Kelowna (CA)
Registration Expires
Dec 31, 2026
Operations
MANUFACTURE
Source
decrs

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