Americare Compounding, LLC
FDA inspection history in Garden City South, New York, 2013 to 2017
- 2
- Form 483s
- 1
- Response
- 1
- Warning letter
Every document, by year
- Response
- Form 483
- Warning letter
2013: one Form 483; 2014: one warning letter; 2015: one Form 483; 2017: one 483 response.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–17Two Form 483s, one warning letter and one 483 response, at Garden City South, New York.
- 2013The longest 483 on file: 12 observations over 5 pages at Garden City South, New York.
Cited most
Across all Americare Compounding observations on file
- 21 CFR 211.42Design and construction features6
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.166Stability testing2
- 21 CFR 211.28Personnel responsibilities2
- 21 CFR 211.100Written procedures; deviations1
The complete Americare Compounding 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
Garden City South, New York
Two Form 483s, one 483 response and one warning letter · 2013 to 2017 · 20 observations
Latest: Response, Mar 22, 2017 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-03-22 | Response 483 response | Garden City South, New York | — | $199 |
| 2015-06-22 | 483 Form 483 | Garden City South, New York | 8 | $99 |
| 2014-04-22 | Warning letter Warning letter | Garden City South, New York | — | $99 |
| 2013-06-19 | 483 Form 483 | Garden City South, New York | 12 | $99 |
Investigators on these documents
FEI number 3010223213 · most recent document Mar 22, 2017
About Americare Compounding, LLC
How many FDA Form 483s has Americare Compounding, LLC received?
FDA Intel has 2 Form 483s on file for Americare Compounding, LLC; the most recent is dated Jun 22, 2015.
When was Americare Compounding, LLC last inspected by FDA?
The most recent FDA inspection document on file for Americare Compounding, LLC is a Form 483 dated Jun 22, 2015, for the site in Garden City South, New York.
What did FDA cite at Americare Compounding, LLC?
The regulations cited most in the observations on file for Americare Compounding, LLC are 21 CFR 211.42 (Design and construction features), 6 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.166 (Stability testing), 2 times.
Has Americare Compounding, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Americare Compounding, LLC; the most recent is dated Apr 22, 2014.