Fallon Wellness Pharmacy, LLC
FDA inspection history in Latham, New York, 2015 to 2020
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2015: one Form 483; 2016: one warning letter; 2018: one close-out letter; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–20Two Form 483s, one warning letter and one close-out letter, at Latham, New York.
- 2020The longest 483 on file: 10 observations over 8 pages at Latham, New York.
Cited most
Across all Fallon Wellness Pharmacy observations on file
- 21 CFR 211.42Design and construction features8
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.167Special testing requirements2
- 21 CFR 211.192Production record review2
The complete Fallon Wellness Pharmacy file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Latham, New York
Two Form 483s, one close-out letter and one warning letter · 2015 to 2020 · 20 observations
Latest: Form 483, Feb 6, 2020 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-02-06 | 483 Form 483 | Latham, New York | 10 | $99 |
| 2018-12-18 | Close-out Close-out letter | Latham, New York | — | $99 |
| 2016-02-01 | Warning letter Warning letter | Latham, New York | — | $99 |
| 2015-03-10 | 483 Form 483 | Latham, New York | 10 | $99 |
Investigators on these documents
FEI number 3007942369 · most recent document Feb 6, 2020
About Fallon Wellness Pharmacy, LLC
How many FDA Form 483s has Fallon Wellness Pharmacy, LLC received?
FDA Intel has 2 Form 483s on file for Fallon Wellness Pharmacy, LLC; the most recent is dated Feb 6, 2020.
When was Fallon Wellness Pharmacy, LLC last inspected by FDA?
The most recent FDA inspection document on file for Fallon Wellness Pharmacy, LLC is a Form 483 dated Feb 6, 2020, for the site in Latham, New York.
What did FDA cite at Fallon Wellness Pharmacy, LLC?
The regulations cited most in the observations on file for Fallon Wellness Pharmacy, LLC are 21 CFR 211.42 (Design and construction features), 8 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.166 (Stability testing), 2 times.
Has Fallon Wellness Pharmacy, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Fallon Wellness Pharmacy, LLC; the most recent is dated Feb 1, 2016.