FDA Inspection 730923 — Syntec Inc
The FDA completed an inspection of Syntec Inc on June 17, 2011 in Hillsboro, WI. 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
- June 17, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Hillsboro, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15482 | 21 CFR 111.23(c) | Records - water |
| 15510 | 21 CFR 111.27(a)(7) | Compressed air, gases |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15673 | 21 CFR 111.315(a) | Criteria for establishing specifications |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15845 | 21 CFR 111.73 | Specifications met - quality |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |