FDA Inspection 679474 — Levlad, LLC
The FDA completed an inspection of Levlad, LLC on Sep 9, 2010 in Chatsworth, CA. 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). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 9, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Chatsworth, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2203 | 21 CFR 211.186(b)(7) | Theoretical Yield and Percentages |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |
| 4392 | 21 CFR 211.186(b)(1) | Name, strength, dosage form |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |