FDA Inspection 640966 — HF Acquisition Co LLC
The FDA completed an inspection of HF Acquisition Co LLC on Jan 19, 2010 in Mukilteo, WA. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 19, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mukilteo, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |