Fischer Pharmaceuticals Ltd.
Form 483 issued July 28, 2022 · TIBERIAS, Israel
- Inspection
- Jul 24 – Jul 28, 2022
- Investigators
- Anastasia M. Shields· Jill Tillman
- Observations
- 12
- Pages
- 9
- FEI number
- 3002750286
In short: On July 28, 2022, FDA issued a Form 483 with 12 observations to Fischer Pharmaceuticals Ltd. in TIBERIAS, Israel (FEI 3002750286) after an inspection that ran Jul 24 – Jul 28, 2022. The investigators were Anastasia M. Shields and Jill Tillman. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
The written stability program for drug products does not include reliable…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmFischer Pharmaceuticals Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fischer Pharmaceuticals Ltd.?
FDA listed 12 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Fischer Pharmaceuticals Ltd.?
Anastasia M. Shields and Jill Tillman are named on this Form 483, for the inspection of Jul 24 – Jul 28, 2022. Each investigator has a profile showing what they cite most.
When was Fischer Pharmaceuticals Ltd. inspected by FDA?
The inspection ran Jul 24 – Jul 28, 2022, and the Form 483 is dated July 28, 2022.
How do I get the full Form 483 for Fischer Pharmaceuticals 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.