FDA Inspection 970577 — Balance Healthcare Limited
The FDA completed an inspection of Balance Healthcare Limited on Apr 26, 2016 in Chipping Norton. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 26, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Chipping Norton (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 15539 | 21 CFR 111.260(a)(1) | Batch record - control number, finished batch |
| 15596 | 21 CFR 111.160(c)(3) | Packaging - quality control; approve, release |
| 15598 | 21 CFR 111.160(d)(1) | Packaging - identify |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15842 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |