FDA Inspection 1070902 — Graxcell USA, LLC
The FDA completed an inspection of Graxcell USA, LLC on Nov 5, 2018 in Paulsboro, NJ. 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
- Nov 5, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Paulsboro, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |