Cosway Company, Inc.
Form 483 issued February 24, 2023 · Carson, California
- Inspection
- Feb 16 – Feb 24, 2023
- Investigator
- Heidy C. Perales
- Observations
- 2
- Pages
- 3
- FEI number
- 3000205953
In short: On February 24, 2023, FDA issued a Form 483 with 2 observations to Cosway Company, Inc. in Carson, California (FEI 3000205953) after an inspection that ran Feb 16 – Feb 24, 2023. The investigator was Heidy C. Perales. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.160(b) (1×) · 211.142(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality…
This inspection in context
Heidy C. Perales
5 documents · 2021–2023
Cites 211.160(b) (general requirements) 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 211.160(b)
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 laboratory controls and materials. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Cosway Company, Inc.?
Heidy C. Perales is named on this Form 483, for the inspection of Feb 16 – Feb 24, 2023. Each investigator has a profile showing what they cite most.
When was Cosway Company, Inc. inspected by FDA?
The inspection ran Feb 16 – Feb 24, 2023, and the Form 483 is dated February 24, 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.