FDA Inspection 1222434 — 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). 13 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 |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15537 | 21 CFR 111.255(d) | Batch record - electronic |
| 15583 | 21 CFR 111.155(d)(1) | Components - identify lot received |
| 15715 | 21 CFR 111.375(b) | Records - manufacturing operations; written procedures |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 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 |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15966 | 21 CFR 111.117(a) | Quality control operations - calibrating processes |