Medlife Pharmacy and Compounding
Form 483 issued April 18, 2018 · Irvine, California
- Inspection
- Apr 9 – Apr 18, 2018
- Investigator
- Yasamin Ameri
- Observations
- 10
- Pages
- 4
- FEI number
- 3014332926
In short: On April 18, 2018, FDA issued a Form 483 with 10 observations to Medlife Pharmacy and Compounding in Irvine, California (FEI 3014332926) after an inspection that ran Apr 9 – Apr 18, 2018. The investigator was Yasamin Ameri. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no written testing program designed to assess the stability…
- 02
The separate or defined areas and control systems necessary to prevent contamination…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
Records are not kept for the maintenance, cleaning, sanitizing…
This inspection in context
Yasamin Ameri
20 documents · 2015–2022
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in India.
The firmMedlife Pharmacy and Compounding history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medlife Pharmacy and Compounding?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Medlife Pharmacy and Compounding?
Yasamin Ameri is named on this Form 483, for the inspection of Apr 9 – Apr 18, 2018. Each investigator has a profile showing what they cite most.
When was Medlife Pharmacy and Compounding inspected by FDA?
The inspection ran Apr 9 – Apr 18, 2018, and the Form 483 is dated April 18, 2018.
How do I get the full Form 483 for Medlife Pharmacy and Compounding?
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.