FDA Inspection 1137401 — Eco Lips, Inc.
The FDA completed an inspection of Eco Lips, Inc. on March 31, 2021 in Cedar Rapids, IA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 31, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cedar Rapids, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1957 | 21 CFR 211.180(e)(2) | Review of problem drugs |
| 3624 | 21 CFR 211.170(a) | Reserve sample quantity - active ingredients only |