Brio Pharmaceuticals, Inc.
Form 483 issued July 11, 2019 · Houston, Texas
- Inspection
- Jun 25 – Jul 11, 2019
- Investigator
- Camerson E. Moore
- Observations
- 6
- Pages
- 6
- FEI number
- 1628196
In short: On July 11, 2019, FDA issued a Form 483 with 6 observations to Brio Pharmaceuticals, Inc. in Houston, Texas (FEI 1628196) after an inspection that ran Jun 25 – Jul 11, 2019. The investigator was Camerson E. Moore. Most observations concern production and quality system.
At a glance
Production and quality system 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
The batch production and control records are deficient in that they are not an accurate reproduction…
- 02
Time limits are not established when appropriate for the completion of each production phase to assure…
- 03
Equipment for adequate control over micro-organisms and dust is not provided when appropriate for the manufacture…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
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 211.188
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 production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Brio Pharmaceuticals, Inc.?
Camerson E. Moore is named on this Form 483, for the inspection of Jun 25 – Jul 11, 2019. Each investigator has a profile showing what they cite most.
When was Brio Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Jun 25 – Jul 11, 2019, and the Form 483 is dated July 11, 2019.
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.