Nora Apothecary and Alternative Therapies, Inc.
Form 483 issued August 21, 2014 · Indianapolis, Indiana
- Inspection
- Aug 6 – Aug 21, 2014
- Investigator
- Larry K. Austin
- Observations
- 6
- Pages
- 2
- FEI number
- 3007181436
In short: On August 21, 2014, 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 Aug 6 – Aug 21, 2014. The investigator was Larry K. Austin. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
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 purporting to be sterile is not laboratory tested to determine…
- 02
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifi cally, environmental mon…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
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 211.167(a)
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 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Nora Apothecary and Alternative Therapies, Inc.?
Larry K. Austin is named on this Form 483, for the inspection of Aug 6 – Aug 21, 2014. Each investigator has a profile showing what they cite most.
When was Nora Apothecary and Alternative Therapies, Inc. inspected by FDA?
The inspection ran Aug 6 – Aug 21, 2014, and the Form 483 is dated August 21, 2014.
How do I get the full Form 483 for Nora Apothecary and Alternative Therapies, 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.