FDA Inspection 1198823 — Reed-Lane, Inc.
The FDA completed an inspection of Reed-Lane, Inc. on March 3, 2023 in Wayne, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 3, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wayne, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |