FDA Inspection 869670 — Tibetan Herbal Balance, Inc.
The FDA completed an inspection of Tibetan Herbal Balance, Inc. on March 5, 2014 in Malden, MA. 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
- March 5, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Malden, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15610 | 21 CFR 111.165(d)(1) | Product received - identify |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15841 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15989 | 21 CFR 111.127 | Quality control operations - packaging, labeling |
| 16014 | 21 CFR 111.140(b)(1) | QC ops; written procedures; material review, disposition |