FDA Inspection 1222416 — Terra Pharma Labs, Inc
The FDA completed an inspection of Terra Pharma Labs, Inc on Nov 8, 2023 in Irving, 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). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 8, 2023
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Irving, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15481 | 21 CFR 111.23(b) | Records - cleaning, pest control |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15610 | 21 CFR 111.165(d)(1) | Product received - identify |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15715 | 21 CFR 111.375(b) | Records - manufacturing operations; written procedures |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |