FDA Inspection 1229615 — Quantum Fulfillment And Support, LLC
The FDA completed an inspection of Quantum Fulfillment And Support, LLC on Jul 26, 2024 in Cedar Creek, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 18 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 26, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Cedar Creek, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15599 | 21 CFR 111.160(d)(1) | Labels - identify |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 16008 | 21 CFR 111.135 | Quality control operations - product complaints; investigate |
| 16047 | 21 CFR 111.510 | Returned dietary supplement - material review, disposition |
| 18397 | 21 CFR 117.4 | Qualifications of individuals |
| 21278 | 21 CFR 117.415(a)(1) | Supply-chain program - Supplier approval |
| 22714 | 21 CFR 117.410(c) | Supply-chain program - Assurance (Adequate) |
| 22717 | 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard |
| 22719 | 21 CFR 117.135(c)(2) | Allergen preventive controls - Appropriate (Adequate) |
| 22720 | 21 CFR 117.135(c)(3) | Sanitation preventive controls - Appropriate (Adequate) |