FDA Inspection 798532 — Cosmo-Pharm, Inc.
The FDA completed an inspection of Cosmo-Pharm, Inc. on September 14, 2012 in North Hollywood, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 14, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- North Hollywood, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15397 | 21 CFR 111.10(b)(7) | Personal belongings |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15507 | 21 CFR 111.27(a)(5)(i) | Refrigerator, freezer - temperature recording device |
| 15509 | 21 CFR 111.27(a)(6) | Instruments, controls - accurate, precise, maintained |
| 15544 | 21 CFR 111.260(d) | Batch record - component; unique identifier |
| 15547 | 21 CFR 111.260(g) | Batch record - results; monitoring |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |