FDA Inspection 1282054 — ChiRhoClin, Inc
The FDA completed an inspection of ChiRhoClin, Inc on September 15, 2025 in Burtonsville, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 15, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Burtonsville, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1956 | 21 CFR 211.180(e)(1) | Representative Number of Batches for Annual Review |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2404 | 21 CFR 211.194(a)(6) | Comparison of Test Results to Specifications |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |