FDA Inspection 658427 — The Hain Celestial Group, Inc.
The FDA completed an inspection of The Hain Celestial Group, Inc. on April 14, 2010 in Boulder, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 26 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 14, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Boulder, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15391 | 21 CFR 111.10(b)(3) | Hand washing |
| 15393 | 21 CFR 111.10(b)(4) | Hand jewelry - remove |
| 15395 | 21 CFR 111.10(b)(5) | Gloves |
| 15396 | 21 CFR 111.10(b)(6) | Hair restraints |
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15429 | 21 CFR 111.15(k) | Sanitation supervisors - assigned |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15456 | 21 CFR 111.20(b) | Physical plant - space; equipment, materials |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15527 | 21 CFR 111.30(c) | Equipment - automated - QC check |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15597 | 21 CFR 111.160(c)(3) | Labels - quality control; approve, release |
| 15671 | 21 CFR 111.315 | Laboratory control processes - requirements |
| 15675 | 21 CFR 111.315(b) | Sampling plans; establish, follow |
| 15679 | 21 CFR 111.315(b)(1) | Laboratory control processes - sampling plans; packaging |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15712 | 21 CFR 111.325(b)(2)(ii) | Records - document; results |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15799 | 21 CFR 111.560(a)(1) | Product complaint - quality control review |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15848 | 21 CFR 111.73 | Specifications met - component purity, strength, composition |
| 15850 | 21 CFR 111.73 | Specifications met in-process purity, strength, composition |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 16051 | 21 CFR 111.525(b) | Returned dietary supplement - release |