FDA Inspection 682274 — Sunrider Manufacturing L.P.
The FDA completed an inspection of Sunrider Manufacturing L.P. on September 20, 2010 in Midlothian, TX. 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 20, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Midlothian, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |