FDA Inspection 653865 — Deltex Pharmaceuticals, Inc
The FDA completed an inspection of Deltex Pharmaceuticals, Inc on April 16, 2010 in Rosenberg, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 16, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Rosenberg, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1168 | 21 CFR 211.34 | Consultant Records |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1939 | 21 CFR 211.167(c) | Controlled release test methods written, followed |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |