Fallon Wellness Pharmacy, LLC
Form 483 issued February 6, 2020 · Latham, New York
- Inspection
- Feb 6, 2020
- Investigators
- Chad N. Thompson· Rajiv R. Srivastava
- Observations
- 10
- Pages
- 8
- FEI number
- 3007942369
In short: On February 6, 2020, FDA issued a Form 483 with 10 observations to Fallon Wellness Pharmacy, LLC in Latham, New York (FEI 3007942369) after an inspection that ran Feb 6, 2020. The investigators were Chad N. Thompson and Rajiv R. Srivastava. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
6 of 10 observations on this 483 concern facilities & equipment.
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
There is a failure to thoroughly review any llllexplained discrepancy and the failure of a batch…
- 02
Aseptic processing ru·eas ru·e deficient regru·ding systems for maintaining any equipment used to…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
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, laboratory controls and quality system. 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 and Rajiv R. Srivastava are named on this Form 483, for the inspection of Feb 6, 2020. Each investigator has a profile showing what they cite most.
When was Fallon Wellness Pharmacy, LLC inspected by FDA?
The inspection ran Feb 6, 2020, and the Form 483 is dated February 6, 2020.
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.