FDA Inspection 743249 — Englewood Lab, Inc
The FDA completed an inspection of Englewood Lab, Inc on August 25, 2011 in Totowa, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 25, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Totowa, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4576 | 21 CFR 211.192 | No written record of investigation |