Absolute Pharmacy, LLC
FDA inspection history in Lutz, Florida, 2014 to 2017
- 2
- Form 483s
- 1
- Response
- 1
- Warning letter
Every document, by year
- Response
- Form 483
- Warning letter
2014: one Form 483; 2015: one warning letter; 2016: one Form 483; 2017: one 483 response.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–17Two Form 483s, one warning letter and one 483 response, at Lutz, Florida.
- 2014The longest 483 on file: 12 observations over 7 pages at Lutz, Florida.
Cited most
Across all Absolute Pharmacy observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.42Design and construction features5
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.192Production record review2
- 21 CFR 211.111Time limitations on production1
The complete Absolute 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
Lutz, Florida
Two Form 483s, one 483 response and one warning letter · 2014 to 2017 · 21 observations
Latest: Response, Feb 15, 2017 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-02-15 | Response 483 response | Lutz, Florida | — | $199 |
| 2016-04-11 | 483 Form 483 | Lutz, Florida | 9 | $99 |
| 2015-04-27 | Warning letter Warning letter | Lutz, Florida | — | $99 |
| 2014-11-19 | 483 Form 483 | Lutz, Florida | 12 | $99 |
Investigators on these documents
FEI number 3011116100 · most recent document Feb 15, 2017
About Absolute Pharmacy, LLC
How many FDA Form 483s has Absolute Pharmacy, LLC received?
FDA Intel has 2 Form 483s on file for Absolute Pharmacy, LLC; the most recent is dated Apr 11, 2016.
When was Absolute Pharmacy, LLC last inspected by FDA?
The most recent FDA inspection document on file for Absolute Pharmacy, LLC is a Form 483 dated Apr 11, 2016, for the site in Lutz, Florida.
What did FDA cite at Absolute Pharmacy, LLC?
The regulations cited most in the observations on file for Absolute Pharmacy, LLC are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.42 (Design and construction features), 5 times; 21 CFR 211.165 (Testing and release for distribution), 2 times.
Has Absolute Pharmacy, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Absolute Pharmacy, LLC; the most recent is dated Apr 27, 2015.