Natures Formulae Health Products Ltd.
Form 483 issued November 3, 2023 · Kelowna, Canada
- Inspection
- Oct 30 – Nov 3, 2023
- Investigator
- Gavin T. Cua
- Observations
- 4
- Pages
- 3
- FEI number
- 3000027163
In short: On November 3, 2023, FDA issued a Form 483 with 4 observations to Natures Formulae Health Products Ltd. in Kelowna, British Columbia (FEI 3000027163) after an inspection that ran Oct 30 – Nov 3, 2023. The investigator was Gavin T. Cua. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Written procedures are not established for evaluations conducted at least annually to review records associated with…
- 03
A sample which is representative of each lot in each shipment of each active…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment…
This inspection in context
Gavin T. Cua
9 documents · 2022–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmNatures Formulae Health Products Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Natures Formulae Health Products Ltd.?
FDA listed 4 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Natures Formulae Health Products Ltd.?
Gavin T. Cua is named on this Form 483, for the inspection of Oct 30 – Nov 3, 2023. Each investigator has a profile showing what they cite most.
When was Natures Formulae Health Products Ltd. inspected by FDA?
The inspection ran Oct 30 – Nov 3, 2023, and the Form 483 is dated November 3, 2023.
How do I get the full Form 483 for Natures Formulae Health Products Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.