FDA Inspection 777813 — Twin Pine Industries, Inc.
The FDA completed an inspection of Twin Pine Industries, Inc. on Apr 10, 2012 in Scandia, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 10, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Scandia, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15774 | 21 CFR 111.415(f)(1) | Batch-lot,control number packaged, labeled dietary supplemen |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15847 | 21 CFR 111.73 | Specifications met - component identity |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |