FDA Inspection 1077561 — Shield Bearer LLC
The FDA completed an inspection of Shield Bearer LLC on Jan 30, 2019 in Azle, TX. 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). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 30, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Azle, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15504 | 21 CFR 111.27(a)(3)(iv) | Equipment - withstand environment |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15893 | 21 CFR 111.80(c) | Specifications - representative samples; finished batch |
| 15970 | 21 CFR 111.120 | Quality control operations - components, packaging, labels |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |