Cosway Company, Inc.
Form 483 issued March 10, 2017 · Long Beach, California
- Inspection
- Feb 27 – Mar 10, 2017
- Investigator
- Stephanie A. Slater
- Observations
- 9
- Pages
- 16
- FEI number
- 3000205953
In short: On March 10, 2017, FDA issued a Form 483 with 9 observations to Cosway Company, Inc. in Long Beach, California (FEI 3000205953) after an inspection that ran Feb 27 – Mar 10, 2017. The investigator was Stephanie A. Slater. Most observations concern quality system and materials.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Complaint records are deficient in that they do not include the findings of the…
- 03
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality…
- 04
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the…
This inspection in context
Stephanie A. Slater
20 documents · 2015–2021
Cites 211.67 (equipment cleaning and maintenance) 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 9 observations on this Form 483, mostly about quality system, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Cosway Company, Inc.?
Stephanie A. Slater is named on this Form 483, for the inspection of Feb 27 – Mar 10, 2017. Each investigator has a profile showing what they cite most.
When was Cosway Company, Inc. inspected by FDA?
The inspection ran Feb 27 – Mar 10, 2017, and the Form 483 is dated March 10, 2017.
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.