FDA Inspection 800566 — Herbs Of Light, Inc.
The FDA completed an inspection of Herbs Of Light, Inc. on Sep 28, 2012 in Alachua, FL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 17 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 28, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Alachua, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15409 | 21 CFR 111.14(b)(1) | Personnel - records - written procedures |
| 15482 | 21 CFR 111.23(c) | Records - water |
| 15507 | 21 CFR 111.27(a)(5)(i) | Refrigerator, freezer - temperature recording device |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15618 | 21 CFR 111.180(b)(1) | Written procedures - components |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15708 | 21 CFR 111.325(a) | Written procedures, laboratory operations |
| 15715 | 21 CFR 111.375(b) | Records - manufacturing operations; written procedures |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15921 | 21 CFR 111.95(b)(2) | Documentation - supplier qualification |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |
| 16065 | 21 CFR 111.35(b)(1) | Written procedures - equipment, utensils; make, keep |