Cosway Company, Inc.
Form 483 issued October 27, 2023 · Carson, California
- Inspection
- Oct 25 – Oct 27, 2023
- Investigator
- Sara H. Gabel
- Observations
- 2
- Pages
- 4
- FEI number
- 3000205953
In short: On October 27, 2023, FDA issued a Form 483 with 2 observations to Cosway Company, Inc. in Carson, California (FEI 3000205953) after an inspection that ran Oct 25 – Oct 27, 2023. The investigator was Sara H. Gabel. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.68 (1×) · 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
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Sara H. Gabel
6 documents · 2022–2025
Cites 211.192 (production record review) 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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cosway Company, Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Cosway Company, Inc.?
Sara H. Gabel is named on this Form 483, for the inspection of Oct 25 – Oct 27, 2023. Each investigator has a profile showing what they cite most.
When was Cosway Company, Inc. inspected by FDA?
The inspection ran Oct 25 – Oct 27, 2023, and the Form 483 is dated October 27, 2023.
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.