# FDA WARNING_LETTER - Eco Lips, Inc. - March 24, 2022

Source: https://www.globalkeysolutions.net/records/warning_letter/eco-lips-inc/d2c4a20a-cb6f-451f-ac19-11adbba13d57

> FDA WARNING_LETTER for Eco Lips, Inc. on March 24, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Eco Lips, Inc.
- Inspection Date: 2022-03-24
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: On September 20, 2022, the FDA issued Warning Letter WL 631629 to Eco Lips, Inc., following an inspection from March 22-24, 2022. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include:
1.  **Inadequate Stability Program (21 CFR 211.166(a)):** The firm failed to establish an adequate written testing program to assess drug product stability and determine expiration dates for OTC drug products. This is a repeat observation from 2019 and 2021 inspections.
2.  **Failure to Investigate OOS Results (21 CFR 211.192):** The firm did not thoroughly investigate out-of-specification (OOS) assay results for several OTC drug product batches, retesting and releasing products without proper investigation. The firm committed to voluntarily recall affected batches.
3.  **Lack of Process Validation (21 CFR 211.100(a)):** The firm failed to provide data demonstrating validated manufacturing processes for all OTC sunscreen drug products, with most groups lacking completed validation studies. This is a repeat observation from 2021.
4.  **Inadequate Cleaning Validation (21 CFR 211.67(b)):**

## 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)
- [483 - 2023-07-14](https://www.globalkeysolutions.net/records/483/eco-lips-inc/76857df9-fe2a-44a1-bba8-ae3cfb828b9c)

## Related Officers

- [Associate Director](https://www.globalkeysolutions.net/people/jeffrey-d-meng/55543677-bd74-4cc5-8a2a-e14afb91d338)

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

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0