FDA Inspection 964369 — Laboratorios Liconsa SAU
The FDA completed an inspection of Laboratorios Liconsa SAU on Feb 12, 2016 in Azuqueca De Henares. 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
- Feb 12, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Azuqueca De Henares (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 17863 | 21 CFR 212.60(g)(3) | Complete record of all laboratory test data |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4576 | 21 CFR 211.192 | No written record of investigation |