Little Moon Essentials LLC
Form 483 issued January 18, 2024 · Dania Beach, Florida
- Inspection
- Jan 16 – Jan 18, 2024
- Investigators
- Mabany Lizardi· Marian E. Ramirez
- Observations
- 5
- Pages
- 5
- FEI number
- 3017366969
In short: On January 18, 2024, FDA issued a Form 483 with 5 observations to Little Moon Essentials LLC in Dania Beach, Florida (FEI 3017366969) after an inspection that ran Jan 16 – Jan 18, 2024. The investigators were Mabany Lizardi and Marian E. Ramirez. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 03
The identity of each component of a drug product is not verified by conducting at least…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Mabany Lizardi
3 documents · 2024
Cites 211.165(a) (testing and release for distribution) more than any other section. Most of their documents are for sites in Florida.
The firmLittle Moon Essentials LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Little Moon Essentials LLC?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, production and materials. The opening words of each observation are shown on this page.
Who inspected Little Moon Essentials LLC?
Mabany Lizardi and Marian E. Ramirez are named on this Form 483, for the inspection of Jan 16 – Jan 18, 2024. Each investigator has a profile showing what they cite most.
When was Little Moon Essentials LLC inspected by FDA?
The inspection ran Jan 16 – Jan 18, 2024, and the Form 483 is dated January 18, 2024.
How do I get the full Form 483 for Little Moon Essentials LLC?
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.