FDA Inspection 1210409 — DHL Supply Chain RN (USA) LLC
The FDA completed an inspection of DHL Supply Chain RN (USA) LLC on Jul 19, 2023 in Arlington, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jul 19, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Arlington, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 18139 | 21 CFR 117.20(a) | Grounds |
| 18141 | 21 CFR 117.35(a) | Sanitary operations - Plant maintenance |
| 18145 | 21 CFR 117.35(c) | Pest control |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 2086 | 21 CFR 211.208 | Salvaging and return to marketplace |
| 22808 | FDCA 501(a)(2)(A) | Insanitary Conditions (FDCA 501(a)(2)(A)) |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |