Ceela Naturals
Form 483 issued August 31, 2021 · Louisville, Kentucky
- Inspection
- Aug 30 – Aug 31, 2021
- Investigators
- Carl A. Huffman· Eboni Funderburk· Muna Algharibeh
- Observations
- 5
- Pages
- 3
- FEI number
- 3009528637
In short: On August 31, 2021, FDA issued a Form 483 with 5 observations to Ceela Naturals in Louisville, Kentucky (FEI 3009528637) after an inspection that ran Aug 30 – Aug 31, 2021. The investigators were Carl A. Huffman, Eboni Funderburk and Muna Algharibeh. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and materials account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Drug product component testing is deficient in that at least one specific test to verify the…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Written production and process control procedures are not followed in the execution of production…
- 04
Changes to written procedures are not reviewed and approved by…
This inspection in context
Carl A. Huffman
11 documents · 2015–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Kansas.
The firmCeela Naturals history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ceela Naturals?
FDA listed 5 observations on this Form 483, mostly about production, materials and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Ceela Naturals?
Carl A. Huffman, Eboni Funderburk and Muna Algharibeh are named on this Form 483, for the inspection of Aug 30 – Aug 31, 2021. Each investigator has a profile showing what they cite most.
When was Ceela Naturals inspected by FDA?
The inspection ran Aug 30 – Aug 31, 2021, and the Form 483 is dated August 31, 2021.
How do I get the full Form 483 for Ceela Naturals?
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.