Form 483 · FEI 1000519695
Form 483 issued February 3, 2020 · Chatsworth, California
- Inspection
- Jan 27 – Feb 3, 2020
- Investigator
- Taichun Qin
- Observations
- 4
- Pages
- 4
- FEI number
- 1000519695
In short: On February 3, 2020, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Chatsworth, California (FEI 1000519695) after an inspection that ran Jan 27 – Feb 3, 2020. The investigator was Taichun Qin. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that…
- 02
Procedures describing the handling of all written and oral complaints regarding a drug…
- 03
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the…
- 04
Laboratory records do not include complete records of any testing and standardization…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) 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 211.25(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 4 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Taichun Qin is named on this Form 483, for the inspection of Jan 27 – Feb 3, 2020. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jan 27 – Feb 3, 2020, and the Form 483 is dated February 3, 2020.
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.