FDA Inspection 1273885 — Atlantis Laboratories, Inc.
The FDA completed an inspection of Atlantis Laboratories, Inc. on Jun 26, 2025 in Conroe, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 26, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Conroe, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1796 | 21 CFR 211.80(d) | Identification of Each Lot in Each Shipment |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |