FDA Inspection 1058687 — Plantimex Distributors, Inc.
The FDA completed an inspection of Plantimex Distributors, Inc. on Jul 12, 2018 in San Diego, 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). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 12, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15381 | 21 CFR 111.8 | Written procedures - hygienic practices |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15610 | 21 CFR 111.165(d)(1) | Product received - identify |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15652 | 21 CFR 111.465(b) | Retain reserve samples - 1 year, 2 years |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |