Owen Biosciences Inc.
Form 483 issued March 27, 2025 · Baton Rouge, Louisiana
- Inspection
- Mar 25 – Mar 27, 2025
- Investigator
- Brittny C. Cargo
- Observations
- 6
- Pages
- 4
- FEI number
- 1000132299
In short: On March 27, 2025, FDA issued a Form 483 with 6 observations to Owen Biosciences Inc. in Baton Rouge, Louisiana (FEI 1000132299) after an inspection that ran Mar 25 – Mar 27, 2025. The investigator was Brittny C. Cargo. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 03
Laboratory records do not include complete records of…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Brittny C. Cargo
14 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) 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 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Owen Biosciences Inc.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Owen Biosciences Inc.?
Brittny C. Cargo is named on this Form 483, for the inspection of Mar 25 – Mar 27, 2025. Each investigator has a profile showing what they cite most.
When was Owen Biosciences Inc. inspected by FDA?
The inspection ran Mar 25 – Mar 27, 2025, and the Form 483 is dated March 27, 2025.
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.