Axium Healthcare Pharmacy (dba Balanced Solutions Compounding)
FDA inspection history in Lake Mary, Florida, 2013
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2013: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013One warning letter and one Form 483, at Lake Mary, Florida.
Cited most
Across all Axium Healthcare Pharmacy (dba Balanced Solutions Compounding) observations on file
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.42(c)(1)Design and construction features2
- 21 CFR 211.165(f)Testing and release for distribution1
- 21 CFR 211.166(b)Stability testing1
- 21 CFR 211.167(a)Special testing requirements1
The complete Axium Healthcare Pharmacy (dba Balanced Solutions Compounding) file.
All 2 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
Lake Mary, Florida
One warning letter and one Form 483 · 2013 · 9 observations
Latest: Warning letter, Jul 16, 2013 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2013-07-16 | Warning letter Warning letter | Lake Mary, Florida | — | $99 |
| 2013-03-15 | 483 Form 483 | Lake Mary, Florida | 9 | $99 |
Investigators on these documents
FEI number 3003254930 · most recent document Jul 16, 2013
About Axium Healthcare Pharmacy (dba Balanced Solutions Compounding)
How many FDA Form 483s has Axium Healthcare Pharmacy (dba Balanced Solutions Compounding) received?
FDA Intel has 1 Form 483 on file for Axium Healthcare Pharmacy (dba Balanced Solutions Compounding); the most recent is dated Mar 15, 2013.
When was Axium Healthcare Pharmacy (dba Balanced Solutions Compounding) last inspected by FDA?
The most recent FDA inspection document on file for Axium Healthcare Pharmacy (dba Balanced Solutions Compounding) is a Form 483 dated Mar 15, 2013, for the site in Lake Mary, Florida.
What did FDA cite at Axium Healthcare Pharmacy (dba Balanced Solutions Compounding)?
The regulations cited most in the observations on file for Axium Healthcare Pharmacy (dba Balanced Solutions Compounding) are 21 CFR 211.113(b) (Control of microbiological contamination), 2 times; 21 CFR 211.42(c)(1) (Design and construction features), 2 times; 21 CFR 211.165(f) (Testing and release for distribution), 1 time.
Has Axium Healthcare Pharmacy (dba Balanced Solutions Compounding) received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Axium Healthcare Pharmacy (dba Balanced Solutions Compounding); the most recent is dated Jul 16, 2013.