FDA Inspection 729944 — Global Sweet Polyols LLC
The FDA completed an inspection of Global Sweet Polyols LLC on June 10, 2011 in Rehoboth, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 10, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Rehoboth, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15577 | 21 CFR 111.155(b) | Visually examine - supplier's invoice |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15652 | 21 CFR 111.465(b) | Retain reserve samples - 1 year, 2 years |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15734 | 21 CFR 111.360 | Manufacturing operations - sanitation |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15787 | 21 CFR 111.410(b) | Packaging - issuance, use |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15842 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 15989 | 21 CFR 111.127 | Quality control operations - packaging, labeling |
| 16000 | 21 CFR 111.130 | Quality control operations - returned dietary supplement |
| 16007 | 21 CFR 111.135 | Quality control operations - product complaints |