FDA Inspection 587033 — SUCO, Inc.
The FDA completed an inspection of SUCO, Inc. on May 21, 2009 in Silver Spring, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 21, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Silver Spring, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |
| 1637 | 21 CFR 211.130(e) | Packaging line inspection after use |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |