# FDA 483 - Eco Lips, Inc. - March 31, 2021

Source: https://www.keypedia.com/records/483/eco-lips-inc/582b95f2-933f-45ca-9b11-ed803c749113

> FDA 483 for Eco Lips, Inc. on March 31, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eco Lips, Inc.
- Inspection Date: 2021-03-31
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Eco Lips Inc, an OTC drug manufacturer in Marion, IA, was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies in quality control, including a lack of stability data for SPF lip balms, inadequate annual quality record evaluations, and incomplete cleaning and process validation. Additionally, the firm failed to retain sufficient reserve samples of active ingredients.

## Related Documents

- [483 - 2019-09-25](https://www.keypedia.com/records/483/eco-lips-inc/79264b7f-fc4e-4b1c-804f-c15a432e8fc6)
- [483 - 2022-03-24](https://www.keypedia.com/records/483/eco-lips-inc/656911f1-11b3-4c1c-ba74-01d12075b5ba)
- [WARNING_LETTER - 2022-03-24](https://www.keypedia.com/records/warning_letter/eco-lips-inc/d2c4a20a-cb6f-451f-ac19-11adbba13d57)
- [483 - 2023-07-14](https://www.keypedia.com/records/483/eco-lips-inc/76857df9-fe2a-44a1-bba8-ae3cfb828b9c)

## Related Officers

- [Supervisory Consumer Safety Officer](https://www.keypedia.com/people/carl-a-huffman/4fa9a65e-2aa5-417c-8369-61edab77c57f)
- [Torrey M. Ward](https://www.keypedia.com/people/torrey-m-ward/e3021951-811e-45a0-a029-69c7cc862fcf)

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

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