FDA Inspection 1076769 — Ryder Integrated Logistics, Inc.
The FDA completed an inspection of Ryder Integrated Logistics, Inc. on Dec 19, 2018 in Burlington, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 19, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Burlington, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1396 | 21 CFR 211.42(c)(2) | Rejected Material Area |
| 1874 | 21 CFR 211.180(b) | Record maintenance 3 years (exempt OTC drugs) |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |