Owen Biosciences Inc.
Form 483 issued February 14, 2020 · Baton Rouge, Louisiana
- Inspection
- Feb 10 – Feb 14, 2020
- Investigator
- Francis Guidry
- Observations
- 9
- Pages
- 6
- FEI number
- 1000132299
In short: On February 14, 2020, FDA issued a Form 483 with 9 observations to Owen Biosciences Inc. in Baton Rouge, Louisiana (FEI 1000132299) after an inspection that ran Feb 10 – Feb 14, 2020. The investigator was Francis Guidry. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
Production and quality system account for 7 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Individuals responsible for supervising the manufacture and processing of a drug product lack the training to…
- 02
Employees engaged in the manufacture and processing of a drug product lack the training required to…
- 03
Routine calibration, inspection and checking of mechanical equipment is not performed according to a written program…
- 04
Master production and control…
This inspection in context
Francis Guidry
5 documents · 2017–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Louisiana.
The firmOwen Biosciences Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.25(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Owen Biosciences Inc.?
FDA listed 9 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Owen Biosciences Inc.?
Francis Guidry is named on this Form 483, for the inspection of Feb 10 – Feb 14, 2020. Each investigator has a profile showing what they cite most.
When was Owen Biosciences Inc. inspected by FDA?
The inspection ran Feb 10 – Feb 14, 2020, and the Form 483 is dated February 14, 2020.
How do I get the full Form 483 for Owen Biosciences 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.