Brio Pharmaceuticals, Inc.
Form 483 issued October 3, 2018 · Houston, Texas
- Inspection
- Aug 21 – Oct 3, 2018
- Investigator
- Stephen D. Brown
- Observations
- 4
- Pages
- 9
- FEI number
- 1628196
In short: On October 3, 2018, FDA issued a Form 483 with 4 observations to Brio Pharmaceuticals, Inc. in Houston, Texas (FEI 1628196) after an inspection that ran Aug 21 – Oct 3, 2018. The investigator was Stephen D. Brown. Most observations concern quality system and facilities & equipment.
At a glance
3 of 4 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
Procedures describing the handling of written and oral complaints related to drug products are…
- 04
Input to and output from the computer and records or data are…
This inspection in context
Stephen D. Brown
42 documents · 2006–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmBrio Pharmaceuticals, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Brio Pharmaceuticals, Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Brio Pharmaceuticals, Inc.?
Stephen D. Brown is named on this Form 483, for the inspection of Aug 21 – Oct 3, 2018. Each investigator has a profile showing what they cite most.
When was Brio Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Aug 21 – Oct 3, 2018, and the Form 483 is dated October 3, 2018.
How do I get the full Form 483 for Brio Pharmaceuticals, 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.