FDA Inspection 790249 — HVL, LLC
The FDA completed an inspection of HVL, LLC on August 6, 2012 in Pittsburgh, PA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 6, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Pittsburgh, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15548 | 21 CFR 111.260(h) | Batch record - results; testing, examination; batch |
| 15565 | 21 CFR 111.260(l)(2) | Batch record - reprocessing, repackaging |
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15784 | 21 CFR 111.410(c) | Packaging, labels - master manufacturing record |
| 15802 | 21 CFR 111.560(c) | Product complaint - review, investigation |
| 15820 | 21 CFR 111.55 | Production, process controls - packaged, labeled |
| 15881 | 21 CFR 111.75(g) | Packaging, labeling - visual examination |
| 15922 | 21 CFR 111.95(b)(3) | Documentation - ensure specifications met |
| 15968 | 21 CFR 111.117(c) | Quality control operations - equipment records |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |
| 16039 | 21 CFR 111.605(c) | Records - electronic |
| 16059 | 21 CFR 111.535(b)(3) | Returned dietary supplement: results; testing, examination |