Cosway Company, Inc.
Form 483 issued April 8, 2011 · Carson, California
- Inspection
- Mar 28 – Apr 8, 2011
- Investigator
- Zachary A. Bogorad
- Observations
- 7
- Pages
- 3
- FEI number
- 3000205953
In short: On April 8, 2011, FDA issued a Form 483 with 7 observations to Cosway Company, Inc. in Carson, California (FEI 3000205953) after an inspection that ran Mar 28 – Apr 8, 2011. The investigator was Zachary A. Bogorad. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Changes to written procedures are not reviewed and approved by…
- 02
The procedures for the annual quality standards record evaluation are deficient in that they do not…
- 03
There is a failure to thoroughly review the failure of a batch or any of its…
- 04
Complaint records are deficient in that they do not include the findings of…
This inspection in context
Zachary A. Bogorad
12 documents · 2011–2020
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Colorado.
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 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cosway Company, Inc.?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Cosway Company, Inc.?
Zachary A. Bogorad is named on this Form 483, for the inspection of Mar 28 – Apr 8, 2011. Each investigator has a profile showing what they cite most.
When was Cosway Company, Inc. inspected by FDA?
The inspection ran Mar 28 – Apr 8, 2011, and the Form 483 is dated April 8, 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.