FDA Inspection 1056562 — Pharmaloz Manufacturing Inc.
The FDA completed an inspection of Pharmaloz Manufacturing Inc. on Jun 21, 2018 in Lebanon, PA. 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
- Jun 21, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lebanon, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3581 | 21 CFR 211.101(d) | Verification of component addition |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |