FDA Inspection 824381 — Exclusive Supplements, Inc.
The FDA completed an inspection of Exclusive Supplements, Inc. on March 21, 2013 in Coraopolis, 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
- March 21, 2013
- Fiscal Year
- 2013
- 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) |
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15842 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15898 | 21 CFR 111.83(b)(1) | Reserve sample -container-closure system |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |
| 15945 | 21 CFR 111.105(i) | QC - required operations packaging/labeling operations |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |
| 16087 | 21 CFR 111.123(b)(4) | Quality control supplier product released assurance not provided package |