Rafa Laboratories Ltd.
FDA inspection history in Jerusalem, Israel, 2017 to 2019
- 2
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two Form 483s, at Jerusalem, Israel.
- 2019The longest 483 on file: 6 observations over 4 pages at Jerusalem, Israel.
Cited most
Across all Rafa Laboratories observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
The complete Rafa Laboratories file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Jerusalem, Israel
Two Form 483s · 2017 to 2019 · 12 observations
Latest: Form 483, Nov 25, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-11-25 | 483 Form 483 | Jerusalem, Israel | 6 | $99 |
| 2017-11-13 | 483 Form 483 | Jerusalem, Israel | 6 | $99 |
Investigators on these documents
Jose O. Hernandez-Guzman (1)Marion Michaelis (1)Saied A. Asbagh (1)Wendy G. Tan (1)
FEI number 3004437307 · most recent document Nov 25, 2019
About Rafa Laboratories Ltd.
How many FDA Form 483s has Rafa Laboratories Ltd. received?
FDA Intel has 2 Form 483s on file for Rafa Laboratories Ltd.; the most recent is dated Nov 25, 2019.
When was Rafa Laboratories Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Rafa Laboratories Ltd. is a Form 483 dated Nov 25, 2019, for the site in Jerusalem, Israel.
What did FDA cite at Rafa Laboratories Ltd.?
The regulations cited most in the observations on file for Rafa Laboratories Ltd. are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.111 (Time limitations on production), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time.