FDA Inspection 1232618 — SUCO, Inc.
The FDA completed an inspection of SUCO, Inc. on February 25, 2024 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 25, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Silver Spring, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1956 | 21 CFR 211.180(e)(1) | Representative Number of Batches for Annual Review |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |