FDA Inspection 986704 — K'an Herb Company, Inc.
The FDA completed an inspection of K'an Herb Company, Inc. on July 27, 2016 in Santa Cruz, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 27, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Santa Cruz, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15443 | 21 CFR 111.15(b)(2) | Physical plant - repair |
| 15468 | 21 CFR 111.20(c)(2) | Physical plant - material review and disposition |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15548 | 21 CFR 111.260(h) | Batch record - results; testing, examination; batch |
| 15551 | 21 CFR 111.260(j)(1) | Batch record - date, each step |
| 15553 | 21 CFR 111.260(j)(2)(i) | Batch record - initials; weighing |
| 15554 | 21 CFR 111.260(j)(2)(ii) | Batch record - initials; verifying weight |
| 15627 | 21 CFR 111.180(b)(3) | Documentation - product received; packaging, labeling |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 15978 | 21 CFR 111.123(a)(2) | Quality control operations - batch production records |