Brio Pharmaceuticals, Inc.
Form 483 issued April 26, 2017 · Houston, Texas
- Inspection
- Apr 11 – Apr 26, 2017
- Investigators
- Shatina R. Alridge· Stephen D. Brown
- Observations
- 6
- Pages
- 5
- FEI number
- 1628196
In short: On April 26, 2017, FDA issued a Form 483 with 6 observations to Brio Pharmaceuticals, Inc. in Houston, Texas (FEI 1628196) after an inspection that ran Apr 11 – Apr 26, 2017. The investigators were Shatina R. Alridge and Stephen D. Brown. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 02
Procedures describing the handling of written and oral complaints related to drug products are…
- 03
There is a failure to thoroughly review the failure of a batch or any of its…
- 04
Written procedures are not followed for evaluations conducted at least annually to review records associated with…
This inspection in context
Shatina R. Alridge
10 documents · 2015–2020
Cites 110.35 (sanitary operations) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Brio Pharmaceuticals, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Brio Pharmaceuticals, Inc.?
Shatina R. Alridge and Stephen D. Brown are named on this Form 483, for the inspection of Apr 11 – Apr 26, 2017. Each investigator has a profile showing what they cite most.
When was Brio Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Apr 11 – Apr 26, 2017, and the Form 483 is dated April 26, 2017.
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.