FDA Inspection 1098750 — Paket Corporation
The FDA completed an inspection of Paket Corporation on Aug 6, 2019 in Chicago, IL. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 6, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 21297 | 21 CFR 211.186(a) | Master production and control records, procedure |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |