# FDA 483 - Eco Lips, Inc. - July 14, 2023

Source: https://www.globalkeysolutions.net/records/483/eco-lips-inc/76857df9-fe2a-44a1-bba8-ae3cfb828b9c

> FDA 483 for Eco Lips, Inc. on July 14, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eco Lips, Inc.
- Inspection Date: 2023-07-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Eco Lips, Inc. in Cedar Rapids, IA, a human drug manufacturer, revealed significant deficiencies in production and process control procedures and documentation. The firm failed to consistently follow written procedures for line clearance and sample collection, and did not adequately investigate out-of-specification results or incorrect labeling incidents, with one observation being a repeat finding. These issues indicate a lack of robust quality control and adherence to manufacturing standards.

## Related Documents

- [483 - 2019-09-25](https://www.globalkeysolutions.net/records/483/eco-lips-inc/79264b7f-fc4e-4b1c-804f-c15a432e8fc6)
- [483 - 2021-03-31](https://www.globalkeysolutions.net/records/483/eco-lips-inc/582b95f2-933f-45ca-9b11-ed803c749113)
- [483 - 2022-03-24](https://www.globalkeysolutions.net/records/483/eco-lips-inc/656911f1-11b3-4c1c-ba74-01d12075b5ba)
- [WARNING_LETTER - 2022-03-24](https://www.globalkeysolutions.net/records/warning_letter/eco-lips-inc/d2c4a20a-cb6f-451f-ac19-11adbba13d57)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/alan-m-barker/cf7b4907-0505-418e-860c-815acd534afe)
- [Monica E. Murie](https://www.globalkeysolutions.net/people/monica-e-murie/2db840df-d69f-4def-9830-fd461bea5507)

Company: https://www.globalkeysolutions.net/companies/eco-lips-inc/42df0992-5d1d-4dd5-b8b9-110b0d5fff88

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8