Brown's Compounding Center, Inc.
Form 483 issued August 11, 2014 · Englewood, Colorado
- Inspection
- Jul 28 – Aug 11, 2014
- Investigators
- Isabel Y. Espinosa· Michael A. Charles
- Observations
- 5
- Pages
- 3
- FEI number
- 3010894019
In short: On August 11, 2014, FDA issued a Form 483 with 5 observations to Brown's Compounding Center, Inc. in Englewood, Colorado (FEI 3010894019) after an inspection that ran Jul 28 – Aug 11, 2014. The investigators were Isabel Y. Espinosa and Michael A. Charles. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 04
The written stability program for drug products does not include reliable, meaningful…
This inspection in context
Isabel Y. Espinosa
4 documents · 2011–2014
Cites 110.80(a)(1) (processes and controls) more than any other section. Most of their documents are for sites in New Mexico.
The firmBrown's Compounding Center, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Brown's Compounding Center, Inc.?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Brown's Compounding Center, Inc.?
Isabel Y. Espinosa and Michael A. Charles are named on this Form 483, for the inspection of Jul 28 – Aug 11, 2014. Each investigator has a profile showing what they cite most.
When was Brown's Compounding Center, Inc. inspected by FDA?
The inspection ran Jul 28 – Aug 11, 2014, and the Form 483 is dated August 11, 2014.
How do I get the full Form 483 for Brown's Compounding Center, Inc.?
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.