# FDA 483 - Organicare Nature's Science, LLC - December 01, 2023

Source: https://www.globalkeysolutions.net/records/483/organicare-natures-science-llc/f7162345-b5dd-4738-982b-63173466ae18

> FDA 483 for Organicare Nature's Science, LLC on December 01, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Organicare Nature's Science, LLC
- Inspection Date: 2023-12-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Organicare Nature's Science, LLC, a drug manufacturer in Austin, TX, was cited for significant deficiencies in its quality control unit, equipment cleaning procedures, and record-keeping during an FDA inspection. Observations included a lack of control over printed paper records, inadequate cleaning validation and procedures for manufacturing equipment, and the absence of individual equipment usage logs. These issues indicate a failure to maintain proper control over manufacturing processes and documentation.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/shanna-n-purdy/7a677cf5-484f-4e9a-91b1-27398411ff32)

Company: https://www.globalkeysolutions.net/companies/organicare-natures-science-llc/e3f593f6-96f2-4f4b-8d2b-012f692ac99f

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab