FDA Inspection 1120161 — Lifequest Creations LLC
The FDA completed an inspection of Lifequest Creations LLC on Mar 9, 2020 in Marietta, GA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 9, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Marietta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |