FDA Inspection 919376 — Istituto Biochimico Italiano Giovanni Lorenzini S.P.A.
The FDA completed an inspection of Istituto Biochimico Italiano Giovanni Lorenzini S.P.A. on Mar 3, 2015 in Aprilia. 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 3, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Aprilia (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 1977 | 21 CFR 211.182 | Dedicated equipment: records part of batch record |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |