FDA Inspection 1158266 — MCACO, LTD
The FDA completed an inspection of MCACO, LTD on Dec 7, 2021 in Grand Prairie, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 7, 2021
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Grand Prairie, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15743 | 21 CFR 111.210(h)(3) | Master manufacturing record - specific actions; quality |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |