FDA Inspection 949776 — Beyond Technology Corporation Nanchang
The FDA completed an inspection of Beyond Technology Corporation Nanchang on November 11, 2015 in Nanchang. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 11, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Nanchang (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 3545 | 21 CFR 211.44 | Adequate lighting not provided |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3573 | 21 CFR 211.101(b) | Measured components for manufacturing |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |