Cosway Company, Inc.
Form 483 issued November 10, 2011 · Carson, California
- Inspection
- Oct 26 – Nov 10, 2011
- Investigator
- Truong X. Nguyen
- Observations
- 1
- Pages
- 1
- FEI number
- 3000205953
In short: On November 10, 2011, FDA issued a Form 483 with 1 observation to Cosway Company, Inc. in Carson, California (FEI 3000205953) after an inspection that ran Oct 26 – Nov 10, 2011. The investigator was Truong X. Nguyen. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into the failure of a batch or any of its components to…
This inspection in context
Truong X. Nguyen
20 documents · 2011–2026
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmCosway Company, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cosway Company, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Cosway Company, Inc.?
Truong X. Nguyen is named on this Form 483, for the inspection of Oct 26 – Nov 10, 2011. Each investigator has a profile showing what they cite most.
When was Cosway Company, Inc. inspected by FDA?
The inspection ran Oct 26 – Nov 10, 2011, and the Form 483 is dated November 10, 2011.
How do I get the full Form 483 for Cosway Company, Inc.?
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.