FDA Inspection 892995 — Exclusive Supplements, Inc.
The FDA completed an inspection of Exclusive Supplements, Inc. on September 16, 2014 in Coraopolis, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 16, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Coraopolis, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15351 | FDCA 761(b)(1) | No AE report made (dietary supplement) |
| 15358 | FDCA 761(c)(1) | Timing of AE report submission (dietary supplement) |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15557 | 21 CFR 111.260(k) | Batch record - packaging, labeling |
| 15562 | 21 CFR 111.260(l)(1) | Batch record - quality control review; production |
| 15605 | 21 CFR 111.165(c) | Product received - quarantine |
| 15610 | 21 CFR 111.165(d)(1) | Product received - identify |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15752 | 21 CFR 111.210(c) | Master manufacturing record - components; weight, measure |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15784 | 21 CFR 111.410(c) | Packaging, labels - master manufacturing record |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15887 | 21 CFR 111.77(c) | Specifications not met - received product identified |