FDA Inspection 987585 — Probi USA Inc
The FDA completed an inspection of Probi USA Inc on September 28, 2016 in Redmond, WA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 28, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Redmond, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15739 | 21 CFR 111.210(h)(3)(ii)(B) | Components; add, verify |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |