FDA Inspection 976576 — Herbal Science International, Inc.
The FDA completed an inspection of Herbal Science International, Inc. on June 21, 2016 in City Of Industry, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 22 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 21, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- City Of Industry, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15392 | 21 CFR 111.10(b)(4) | Jewelry and objects - remove |
| 15409 | 21 CFR 111.14(b)(1) | Personnel - records - written procedures |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15444 | 21 CFR 111.15(c)(1) | Cleaning compounds |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |