FDA Inspection 770428 — MADE Inc.
The FDA completed an inspection of MADE Inc. on March 29, 2012 in Oakmont, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 18 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 29, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Oakmont, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15548 | 21 CFR 111.260(h) | Batch record - results; testing, examination; batch |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15662 | 21 CFR 111.303 | Written procedures - laboratory operations |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15780 | 21 CFR 111.415 | Fill, assemble, package, label - master record |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15820 | 21 CFR 111.55 | Production, process controls - packaged, labeled |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |
| 15951 | 21 CFR 111.110(c) | Quality control operations - tests, examinations; results |
| 15953 | 21 CFR 111.113(a)(1) | Quality control production, process control; material review, disposition |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |