Company
PolandPrzedsiebiorstwo Farmaceutyczne Jelfa SA, Jelenia Gora, Poland – FDA Inspections
Inspection records and compliance data for Przedsiebiorstwo Farmaceutyczne Jelfa SA in Jelenia Gora. 6 FDA inspections on record (1 OAI), last inspected November 25, 2022.
Company Profile
This profile covers Przedsiebiorstwo Farmaceutyczne Jelfa SA based in Jelenia Gora, Poland.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 3
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected October 22, 2010. Last inspected November 25, 2022.
Most cited issue areas
- Adequate lab facilities not available1 inspection
- Calculations performed are in the records1 inspection
- Complete Test Data1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 25, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1217692 |
| March 13, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1050200 |
| September 22, 2016 | VAI | Human Drugs · Drug Quality Assurance | 991418 |
| June 30, 2014 | NAI | Human Drugs · Drug Quality Assurance | 885404 |
| May 15, 2012 | VAI | Human Drugs · Drug Quality Assurance | 794037 |
| October 22, 2010 | OAI | Human Drugs · Drug Quality Assurance | 700751 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Przedsiebiorstwo Farmaceutyczne Jelfa SA
FEI Number
3004680543
Address
Ul. Wincentego Pola 21, Jelenia Gora, Poland
Country
Poland
ID: 3d2ceb51-ed6f-4cb0-8788-7a2c39cd1650