Fallon Wellness Pharmacy, LLC
Form 483 issued March 10, 2015 · Latham, New York
- Inspection
- Mar 2 – Mar 10, 2015
- Investigator
- Chad N. Thompson
- Observations
- 10
- Pages
- 5
- FEI number
- 3007942369
In short: On March 10, 2015, FDA issued a Form 483 with 10 observations to Fallon Wellness Pharmacy, LLC in Latham, New York (FEI 3007942369) after an inspection that ran Mar 2 – Mar 10, 2015. The investigator was Chad N. Thompson. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 6 of 10 observations.
Most cited: 21 CFR 211.42 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 02
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 03
There is a failure to thoroughly review the failure of a batch or any of its…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Chad N. Thompson
7 documents · 2013–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmFallon Wellness Pharmacy, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fallon Wellness Pharmacy, LLC?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 Fallon Wellness Pharmacy, LLC?
Chad N. Thompson is named on this Form 483, for the inspection of Mar 2 – Mar 10, 2015. Each investigator has a profile showing what they cite most.
When was Fallon Wellness Pharmacy, LLC inspected by FDA?
The inspection ran Mar 2 – Mar 10, 2015, and the Form 483 is dated March 10, 2015.
How do I get the full Form 483 for Fallon Wellness Pharmacy, 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.