FDA Inspection
Przedsiebiorstwo Farmaceutyczne Jelfa SAPrzedsiebiorstwo Farmaceutyczne Jelfa SA – FDA Inspection, May 15, 2012
Record Details
This FDA Inspection record concerns Przedsiebiorstwo Farmaceutyczne Jelfa SA, with an inspection on May 15, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 15, 2012
- Product Type
- Drugs
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ID · b0eacfd8-73e1-403d-ae2d-36614fcaebbb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 794037
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.194(b)Test method modification records not maintained
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.194(a)(5)Calculations performed are in the records
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.194(a)(2)Laboratory Test Method Verification
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Przedsiebiorstwo Farmaceutyczne Jelfa SA
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 25, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 13, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 22, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 30, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 22, 2010 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Przedsiebiorstwo Farmaceutyczne Jelfa SA
- FDA Inspection 1217692 - 2022-11-25
- FDA Inspection 1050200 - 2018-03-13
- FDA Inspection 991418 - 2016-09-22
- FDA Inspection 885404 - 2014-06-30
- FDA Inspection 700751 - 2010-10-22
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