FDA Inspection 682445 — Gaspari Nutra LLC
The FDA completed an inspection of Gaspari Nutra LLC on November 1, 2010 in Lakewood, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 1, 2010
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lakewood, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15382 | 21 CFR 111.8 | Written procedures - personnel qualifications |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15799 | 21 CFR 111.560(a)(1) | Product complaint - quality control review |
| 15801 | 21 CFR 111.560(b) | Quality control, review, approve; investigate, follow-up |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15816 | 21 CFR 111.570(b)(2)(ii)(E) | Record - product complaint; reply |
| 15817 | 21 CFR 111.570(b)(2)(ii)(F) | Record - product complaint; findings |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 16037 | 21 CFR 111.605 | Records - keep: 1 year, 2 years |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |