FDA Inspection 1203129 — Hikma Farmaceutica, (Portugal) S.A.
The FDA completed an inspection of Hikma Farmaceutica, (Portugal) S.A. on Apr 21, 2023 in Terrugem Snt. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 21, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Terrugem Snt (Portugal)
Citations
| ID | CFR | Description |
|---|---|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4343 | 21 CFR 211.160(b)(1) | Incoming lots - conformance to written specs- |