Axium Healthcare Pharmacy (dba Balanced Solutions Compounding)
Form 483 issued March 15, 2013 · Lake Mary, Florida
- Inspection
- Mar 12 – Mar 15, 2013
- Investigators
- Brian D. Nicholson· German Rivera· Thomas E. Friel
- Observations
- 9
- Pages
- 6
- FEI number
- 3003254930
In short: On March 15, 2013, FDA issued a Form 483 with 9 observations to Axium Healthcare Pharmacy (dba Balanced Solutions Compounding) in Lake Mary, Florida (FEI 3003254930) after an inspection that ran Mar 12 – Mar 15, 2013. The investigators were Brian D. Nicholson, German Rivera and Thomas E. Friel. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Laboratory controls and facilities & equipment account for 6 of 9 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Drug products failing to meet established standards, specifications, and quality control…
- 02
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Brian D. Nicholson
20 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmAxium Healthcare Pharmacy (dba Balanced Solutions Compounding) history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Axium Healthcare Pharmacy (dba Balanced Solutions Compounding)?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Axium Healthcare Pharmacy (dba Balanced Solutions Compounding)?
Brian D. Nicholson, German Rivera and Thomas E. Friel are named on this Form 483, for the inspection of Mar 12 – Mar 15, 2013. Each investigator has a profile showing what they cite most.
When was Axium Healthcare Pharmacy (dba Balanced Solutions Compounding) inspected by FDA?
The inspection ran Mar 12 – Mar 15, 2013, and the Form 483 is dated March 15, 2013.
How do I get the full Form 483 for Axium Healthcare Pharmacy (dba Balanced Solutions Compounding)?
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.