FDA Inspection 727375 — Mericon Industries Inc.
The FDA completed an inspection of Mericon Industries Inc. on May 27, 2011 in Peoria, IL. 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
- May 27, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Peoria, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4375 | 21 CFR 211.188(b)(5) | In-process and laboratory control results |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |