FDA Inspection 948685 — POM Wonderful, LLC
The FDA completed an inspection of POM Wonderful, LLC on December 1, 2015 in Del Rey, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 24 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 1, 2015
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Del Rey, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12748 | 21 CFR 120.8(b)(5) | HACCP plan - corrective action plan not included |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15615 | 21 CFR 111.180(a) | Records - components, packaging, labels, product received: |
| 15649 | 21 CFR 111.465(a)(1) | Hold - reserve samples; ordinary storage |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15708 | 21 CFR 111.325(a) | Written procedures, laboratory operations |
| 15712 | 21 CFR 111.325(b)(2)(ii) | Records - document; results |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15846 | 21 CFR 111.73 | Specifications met - packaged, labeled, master record |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15922 | 21 CFR 111.95(b)(3) | Documentation - ensure specifications met |
| 15923 | 21 CFR 111.95(b)(4) | Documentation - specifications met; test, examinations |
| 15924 | 21 CFR 111.95(b)(5) | Documentation - exempted product specification met |
| 15949 | 21 CFR 111.110(a) | QC-Laboratory control processes; production, process control |
| 15967 | 21 CFR 111.117(b) | Quality control operations - calibration records |
| 9931 | 21 CFR 120.6(b) | Sanitation monitoring |
| 9955 | 21 CFR 120.11(a)(1) | Verification activities - minimum |