FDA Inspection 853049 — YoungYou International
The FDA completed an inspection of YoungYou International on October 31, 2013 in Winnetka, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 31, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Winnetka, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15652 | 21 CFR 111.465(b) | Retain reserve samples - 1 year, 2 years |
| 15783 | 21 CFR 111.410(d) | Manufacturing history |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15989 | 21 CFR 111.127 | Quality control operations - packaging, labeling |