FDA Inspection 784000 — Konsyl Pharmaceuticals Inc
The FDA completed an inspection of Konsyl Pharmaceuticals Inc on May 31, 2012 in Easton, MD. 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 31, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Easton, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4576 | 21 CFR 211.192 | No written record of investigation |