FDA Inspection
Eco Lips, Inc.Eco Lips, Inc. – FDA Inspection, Mar 24, 2022
Record Details
This FDA Inspection record concerns Eco Lips, Inc., with an inspection on March 24, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Eco Lips, Inc.
- Inspection Date
- March 24, 2022
- Product Type
- Drugs
View Company Profile
ID · 8c9feb6f-49e3-4e97-a986-513e612bb1dd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1165260
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
6- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Eco Lips, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 29, 2026 | Not classified | Kansas City District Office | Drug Quality Assurance |
| July 14, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 31, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 25, 2019 | Not classified | Kansas City District Office | Drug Quality Assurance |
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