Rafa Laboratories Ltd.
Form 483 issued November 25, 2019 · Jerusalem, Israel
- Inspection
- Nov 17 – Nov 25, 2019
- Investigator
- Saied A. Asbagh
- Observations
- 6
- Pages
- 4
- FEI number
- 3004437307
In short: On November 25, 2019, FDA issued a Form 483 with 6 observations to Rafa Laboratories Ltd. in Jerusalem, Israel (FEI 3004437307) after an inspection that ran Nov 17 – Nov 25, 2019. The investigator was Saied A. Asbagh. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Batch production and control records do not include complete information relating to the production and…
- 02
Time limits are not established when appropriate for the completion of each production phase to assure…
- 03
Written records of investigations into unexplained discrepancies do not include…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Saied A. Asbagh
12 documents · 2016–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmRafa Laboratories Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.186
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rafa Laboratories Ltd.?
FDA listed 6 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Rafa Laboratories Ltd.?
Saied A. Asbagh is named on this Form 483, for the inspection of Nov 17 – Nov 25, 2019. Each investigator has a profile showing what they cite most.
When was Rafa Laboratories Ltd. inspected by FDA?
The inspection ran Nov 17 – Nov 25, 2019, and the Form 483 is dated November 25, 2019.
How do I get the full Form 483 for Rafa Laboratories Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.