Nora Apothecary dba Rx Compounding, LLC
Form 483 issued August 19, 2016 · Indianapolis, Indiana
- Inspection
- Aug 8 – Aug 19, 2016
- Investigator
- Robert M. Barbosa
- Observations
- 8
- Pages
- 4
- FEI number
- 3007181
In short: On August 19, 2016, FDA issued a Form 483 with 8 observations to Nora Apothecary dba Rx Compounding, LLC in Indianapolis, Indiana (FEI 3007181) after an inspection that ran Aug 8 – Aug 19, 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
5 of 8 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (5×) · 211.42 (2×)
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 performing aseptic manipulations that blocked the movement of first pass air around an…
- 03
Personnel engaged in aseptic processing were…
- 04
ISO 5 classified area is located…
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 dba Rx Compounding, LLC history
The site's inspection history, in date order.
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 dba Rx Compounding, LLC?
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 dba Rx Compounding, LLC?
Robert M. Barbosa is named on this Form 483, for the inspection of Aug 8 – Aug 19, 2016. Each investigator has a profile showing what they cite most.
When was Nora Apothecary dba Rx Compounding, LLC inspected by FDA?
The inspection ran Aug 8 – Aug 19, 2016, and the Form 483 is dated August 19, 2016.
How do I get the full Form 483 for Nora Apothecary dba Rx Compounding, LLC?
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.