FDA Inspection 794037 — Przedsiebiorstwo Farmaceutyczne Jelfa SA
The FDA completed an inspection of Przedsiebiorstwo Farmaceutyczne Jelfa SA on May 15, 2012 in Jelenia Gora. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 15, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Jelenia Gora (Poland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2032 | 21 CFR 211.194(b) | Test method modification records not maintained |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4410 | 21 CFR 211.194(a)(5) | Calculations performed are in the records |