Nora Apothecary and Alternative Therapies, Inc.
Form 483 issued September 16, 2016 · Indianapolis, Indiana
- Inspection
- Aug 8, 2016
- Investigator
- Robert M. Barbosa
- Observations
- 8
- Pages
- 4
- FEI number
- 3007181436
In short: On September 16, 2016, FDA issued a Form 483 with 8 observations to Nora Apothecary and Alternative Therapies, Inc. in Indianapolis, Indiana (FEI 3007181436) after an inspection that ran Aug 8, 2016. The investigator was Robert M. Barbosa. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 8 of 8 observations.
Most cited: 21 CFR 211.113 (4×) · 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment, materials, and/or supplies are not adequately disinfected prior to entering…
- 02
Personnel were observed perform ing asept ic manipulations that blocked the movement of first pass air…
- 03
Personnel engaged in aseptic processing were…
- 04
The ISO 5 classified area is located within…
This inspection in context
Robert M. Barbosa
13 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) 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 211.113
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 8 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Nora Apothecary and Alternative Therapies, Inc.?
Robert M. Barbosa is named on this Form 483, for the inspection of Aug 8, 2016. 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 8, 2016, and the Form 483 is dated September 16, 2016.
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.