FDA Inspection 779366 — HSAC Enterprises, Inc.
The FDA completed an inspection of HSAC Enterprises, Inc. on May 1, 2012 in York, ME. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- May 1, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- York, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |