# FDA 483 - Kaylaan LLC - March 01, 2024

Source: https://www.globalkeysolutions.net/records/483/kaylaan-llc/bb7ec773-f682-45e4-b870-73e9909806fe

> FDA 483 for Kaylaan LLC on March 01, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kaylaan LLC
- Inspection Date: 2024-03-01
- Product Type: drugs
- Office Name: Office of Human and Animal Foods Operations - East
- Summary: Kaylaan LLC, an OTC drug manufacturer in Floral Park, NY, received a Form 483 with 13 observations highlighting severe deficiencies across its quality system and manufacturing operations. Key issues include the complete absence of a quality control unit, lack of essential testing (release, in-process, raw material identity, stability), unvalidated processes and equipment, inadequate documentation, and poor facility maintenance. These findings indicate a fundamental failure to adhere to CGMP requirements for its Kaylaan Toothpaste Tablets with Fluoride.

## Related Documents

- [483 - 2024-03-01](https://www.globalkeysolutions.net/records/483/kaylaan-llc/e0b0d394-29cf-4270-9f26-ec3a4b086df6)
- [WARNING_LETTER - 2024-03-01](https://www.globalkeysolutions.net/records/warning_letter/kaylaan-llc/a246f214-82dc-4389-bba3-f59874063118)

## Related Officers

- [Vivin George](https://www.globalkeysolutions.net/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)

Company: https://www.globalkeysolutions.net/companies/kaylaan-llc/3e07f9e4-5db1-4c3c-87c9-13b7026892ef

Office: https://www.globalkeysolutions.net/offices/office-of-human-and-animal-foods-operations-east/f35344fc-4cf2-4605-b1cf-163d65050588