Brookfield Prescription Center dba MD Custom Rx
Form 483 issued December 13, 2013 · Brookfield, Wisconsin
- Inspection
- Dec 3 – Dec 13, 2013
- Investigators
- Jasjeet K. Sekhon· Sandra A. Hughes
- Observations
- 7
- Pages
- 8
- FEI number
- 3010538416
In short: On December 13, 2013, FDA issued a Form 483 with 7 observations to Brookfield Prescription Center dba MD Custom Rx in Brookfield, Wisconsin (FEI 3010538416) after an inspection that ran Dec 3 – Dec 13, 2013. The investigators were Jasjeet K. Sekhon and Sandra A. Hughes. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Jasjeet K. Sekhon
1 document · 2013
Cites 211.100(b) (written procedures; deviations) more than any other section. Most of their documents are for sites in Wisconsin.
The firmBrookfield Prescription Center dba MD Custom Rx history
The site's inspection history, in date order.
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 Brookfield Prescription Center dba MD Custom Rx?
FDA listed 7 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Brookfield Prescription Center dba MD Custom Rx?
Jasjeet K. Sekhon and Sandra A. Hughes are named on this Form 483, for the inspection of Dec 3 – Dec 13, 2013. Each investigator has a profile showing what they cite most.
When was Brookfield Prescription Center dba MD Custom Rx inspected by FDA?
The inspection ran Dec 3 – Dec 13, 2013, and the Form 483 is dated December 13, 2013.
How do I get the full Form 483 for Brookfield Prescription Center dba MD Custom Rx?
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.