Brown's Compounding Center, Inc.
Form 483 issued April 27, 2015 · Englewood, Colorado
- Inspection
- Apr 20 – Apr 27, 2015
- Investigators
- Erika V. Butler· Tomika L. Bivens
- Observations
- 6
- Pages
- 3
- FEI number
- 3010894019
In short: On April 27, 2015, FDA issued a Form 483 with 6 observations to Brown's Compounding Center, Inc. in Englewood, Colorado (FEI 3010894019) after an inspection that ran Apr 20 – Apr 27, 2015. The investigators were Erika V. Butler and Tomika L. Bivens. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and laboratory controls account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
The written stability program for drug products does not include reliable, meaningful…
This inspection in context
Erika V. Butler
23 documents · 2007–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
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 211.100(a)
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 6 observations on this Form 483, mostly about production, laboratory controls and packaging & labeling. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Brown's Compounding Center, Inc.?
Erika V. Butler and Tomika L. Bivens are named on this Form 483, for the inspection of Apr 20 – Apr 27, 2015. Each investigator has a profile showing what they cite most.
When was Brown's Compounding Center, Inc. inspected by FDA?
The inspection ran Apr 20 – Apr 27, 2015, and the Form 483 is dated April 27, 2015.
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.