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

Source: https://www.keypedia.com/records/483/little-moon-essentials-llc/5b9e0374-07cf-4538-b253-9a96115f321e

> 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: Florida District Office
- Summary: During an inspection conducted from January 16-18, 2024, the Food and Drug Administration (FDA) issued a Form 483 to a pharmaceutical firm, citing significant deficiencies across its laboratory, production, and quality systems. These observations indicate non-compliance with current Good Manufacturing Practices (cGMP) as outlined by the Federal Food, Drug, and Cosmetic Act. Key violations in the laboratory control system included the failure to perform essential testing for drug product conformance to final specifications, including identity and strength, prior to market release. The firm also lacked documented final specifications and failed to conduct antimicrobial effectiveness testing for products using certain water. Furthermore, raw materials were used without identity testing, relying solely on supplier Certificates of Analysis, and no supplier qualification program was in place. Stability testing programs to support product shelf life were also absent. In the production system, the firm failed to establish written procedures for critical production and process controls, leading to a lack of assurance regarding drug product identity, strength, purity, and quality. There was no documentation of process validation or scientific evidence to support manufacturing methods. Significant issues were also noted in the quality system, where the quality control unit lacked written responsibilities and proper oversight. There were no documented procedures for investigations, complaints, corrective actions, change controls, or employee training, including annual cGMP training. Additionally, drug product labels were found to be uncontrolled, mixed with non-drug labels, and lacked proper segregation and security. To achieve compliance, the firm is required to promptly address all noted observations by implementing robust quality systems, establishing comprehensive written procedures, conducting necessary product and material testing, and ensuring proper training for all personnel.

## Related Documents

- [483 - 2024-01-18](https://www.keypedia.com/records/483/little-moon-essentials-llc/db5cbd0b-5c06-41b1-a9b1-df5b11299830)
- [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/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9