FDA Inspection 1034707 — Phalada Agro Research Foundation Pvt. Ltd.
The FDA completed an inspection of Phalada Agro Research Foundation Pvt. Ltd. on December 13, 2017 in Bangalore. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 13, 2017
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Bangalore (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1300 | 21 CFR 113.81(c) | Fill |
| 1330 | 21 CFR 113.100(a) | Process records - forms missing information |
| 1487 | 21 CFR 113.87(b) | Visual indicators not used |
| 16286 | 21 CFR 113.87(c) | Temperature-indicating device accuracy - initial temperature |
| 16292 | 21 CFR 113.100(c)(3) | Accuracy record: accuracy test |
| 1640 | 21 CFR 113.100(b) | Record form not signed |
| 1642 | 21 CFR 113.100(b) | Review not signed/dated |
| 18140 | 21 CFR 117.20(b) | Plant construction and design |
| 2169 | 21 CFR 113.40(b)(10) | Operator check, record, frequency |
| 3877 | 21 CFR 113.60(c) | Coding - required elements |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |
| 4524 | 21 CFR 108.35(g) | Approved school |