American National Red Cross Indiana-Ohio Region
Form 483 issued July 21, 2010 · Fort Wayne, Indiana
- Inspection
- Jul 12 – Jul 21, 2010
- Investigators
- Cynthia V. Vechinski· David L. Sowers
- Observations
- 2
- Pages
- 2
- FEI number
- 1873031
In short: On July 21, 2010, FDA issued a Form 483 with 2 observations to American National Red Cross Indiana-Ohio Region in Fort Wayne, Indiana (FEI 1873031) after an inspection that ran Jul 12 – Jul 21, 2010. The investigators were Cynthia V. Vechinski and David L. Sowers. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.170 (adverse reaction file).
At a glance
Observations span 1 system, led by biologics cgmp.
Most cited: 21 CFR 606.170 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A failure to follow the Amended Consent Decree of Permanent Injunction #93-0949 dated April 15, 2003…
- 02
Failure to perform a thorough investigation, including conclusions and follow up of each…
This inspection in context
Cynthia V. Vechinski
1 document · 2010
Cites 606.170 (adverse reaction file) more than any other section. Most of their documents are for sites in Indiana.
The firmAmerican National Red Cross Indiana-Ohio Region history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.170
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American National Red Cross Indiana-Ohio Region?
FDA listed 2 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.170 (adverse reaction file). The opening words of each observation are shown on this page.
Who inspected American National Red Cross Indiana-Ohio Region?
Cynthia V. Vechinski and David L. Sowers are named on this Form 483, for the inspection of Jul 12 – Jul 21, 2010. Each investigator has a profile showing what they cite most.
When was American National Red Cross Indiana-Ohio Region inspected by FDA?
The inspection ran Jul 12 – Jul 21, 2010, and the Form 483 is dated July 21, 2010.
How do I get the full Form 483 for American National Red Cross Indiana-Ohio Region?
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