FDA Inspection 1042684 — Planet Health Packaging, Inc.
The FDA completed an inspection of Planet Health Packaging, Inc. on March 1, 2018 in Port Jervis, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 1, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Port Jervis, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1554 | 21 CFR 110.35(a) | Cleaning and sanitizing operations |
| 1597 | 21 CFR 110.37(b)(3) | As source of contamination |
| 1711 | 21 CFR 110.80(b)(15) | Proper pH controls |
| 2386 | 21 CFR 110.80(a)(1) | Storage |
| 3071 | 21 CFR 114.80(a)(1) | Scheduled process |
| 3078 | 21 CFR 114.80(b) | Code - required elements |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 3082 | 21 CFR 114.89 | Process deviation |
| 3085 | 21 CFR 114.100(a) | Raw materials, packaging, finished product |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |
| 4511 | 21 CFR 108.25(f) | Approved school |