Form 483 · FEI 1000519695
Form 483 issued May 25, 2018 · Chatsworth, California
- Inspection
- May 21 – May 25, 2018
- Investigator
- Fy I. Eae
- Observations
- 8
- Pages
- 8
- FEI number
- 1000519695
In short: On May 25, 2018, FDA issued a Form 483 with 8 observations to an FDA-inspected site in Chatsworth, California (FEI 1000519695) after an inspection that ran May 21 – May 25, 2018. The investigator was Fy I. Eae. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Employees engaged in the manufacture, processing and packing of a drug product lack the training required…
- 03
Control procedures are not established which of those manufacturing processes that may be responsible for causing…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Fy I. Eae
1 document · 2018
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
The firmSite history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 8 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Fy I. Eae is named on this Form 483, for the inspection of May 21 – May 25, 2018. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran May 21 – May 25, 2018, and the Form 483 is dated May 25, 2018.
How do I get the full Form 483 for an FDA-inspected site?
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.