FDA Inspection 1116922 — Pro-Blending LLC
The FDA completed an inspection of Pro-Blending LLC on February 5, 2020 in Rahway, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 5, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rahway, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 3581 | 21 CFR 211.101(d) | Verification of component addition |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |
| 4379 | 21 CFR 211.188(b)(1) | Dates not included for each significant step |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |