FDA Inspection 993771 — Robert Busse & Co., Inc.
The FDA completed an inspection of Robert Busse & Co., Inc. on Oct 19, 2016 in Hauppauge, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 19, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3175 | 21 CFR 820.186 | QSR |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |