FDA Inspection 1113626 — Delightful Gardens Enterprise Limited
The FDA completed an inspection of Delightful Gardens Enterprise Limited on December 17, 2019 in Junction. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 17, 2019
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Junction (Jamaica)
Citations
| ID | CFR | Description |
|---|---|---|
| 15381 | 21 CFR 111.8 | Written procedures - hygienic practices |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15774 | 21 CFR 111.415(f)(1) | Batch-lot,control number packaged, labeled dietary supplemen |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15939 | 21 CFR 111.105(g) | Quality control - reserve samples |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |