# FDA 483 - Little Moon Essentials LLC - January 18, 2024

Source: https://www.keypedia.com/records/483/little-moon-essentials-llc/db5cbd0b-5c06-41b1-a9b1-df5b11299830

> FDA 483 for Little Moon Essentials LLC on January 18, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Little Moon Essentials LLC
- Inspection Date: 2024-01-18
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Little Moon Essentials LLC, a drug manufacturer in Dania Beach, FL, was cited for significant deficiencies across its laboratory, production, and quality control systems. The firm failed to perform essential product and raw material testing, lacked written procedures for critical manufacturing processes and quality oversight, and did not have an adequate stability testing program or employee training. These issues indicate a severe lack of adherence to good manufacturing practices, potentially compromising drug product quality and safety.

## Related Documents

- [483 - 2025-07-10](https://www.keypedia.com/records/483/little-moon-essentials-llc/654b50c0-e761-4fbb-af02-44644b7c091e)

## Related Officers

- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)
- [Mabany Lizardi](https://www.keypedia.com/people/mabany-lizardi/adcca71c-e996-44e5-9827-d1aa2773e832)

Company: https://www.keypedia.com/companies/little-moon-essentials-llc/6ae9f101-e61d-4443-93cf-7502ae9a1a8c

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6
