FDA Inspection 719452 — MADE Inc.
The FDA completed an inspection of MADE Inc. on April 12, 2011 in Oakmont, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 12, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Oakmont, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15351 | FDCA 761(b)(1) | No AE report made (dietary supplement) |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15510 | 21 CFR 111.27(a)(7) | Compressed air, gases |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15646 | 21 CFR 111.460(a) | Hold, identify - in-process material |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15781 | 21 CFR 111.415 | Fill, assemble, package, label - quality |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |