FDA Inspection 847928 — Komal Herbals, Inc
The FDA completed an inspection of Komal Herbals, Inc on September 25, 2013 in Burgettstown, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 25, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Burgettstown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15607 | 21 CFR 111.165(c)(2) | Product received - quality control; documentation; specs |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15855 | 21 CFR 111.73 | Specifications met - received product identified |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |