Nora Apothecary and Alternative Therapies, Inc.
Form 483 issued March 21, 2013 · Indianapolis, Indiana
- Inspection
- Mar 19 – Mar 21, 2013
- Investigators
- Larry K. Austin· Marie A. Fadden
- Observations
- 6
- Pages
- 3
- FEI number
- 3007181436
In short: On March 21, 2013, FDA issued a Form 483 with 6 observations to Nora Apothecary and Alternative Therapies, Inc. in Indianapolis, Indiana (FEI 3007181436) after an inspection that ran Mar 19 – Mar 21, 2013. The investigators were Larry K. Austin and Marie A. Fadden. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and facilities & equipment account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Environmental monitoring of the…
This inspection in context
Larry K. Austin
3 documents · 2013–2014
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in Indiana.
The firmNora Apothecary and Alternative Therapies, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nora Apothecary and Alternative Therapies, Inc.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Nora Apothecary and Alternative Therapies, Inc.?
Larry K. Austin and Marie A. Fadden are named on this Form 483, for the inspection of Mar 19 – Mar 21, 2013. Each investigator has a profile showing what they cite most.
When was Nora Apothecary and Alternative Therapies, Inc. inspected by FDA?
The inspection ran Mar 19 – Mar 21, 2013, and the Form 483 is dated March 21, 2013.
How do I get the full Form 483 for Nora Apothecary and Alternative Therapies, Inc.?
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