OFD Biopharma, LLC
Form 483 issued July 1, 2022 · Albany, Oregon
- Inspection
- Jun 27 – Jul 1, 2022
- Investigators
- Rowena S. Nguyen· Sara H. Gabel
- Observations
- 3
- Pages
- 5
- FEI number
- 3022538
In short: On July 1, 2022, FDA issued a Form 483 with 3 observations to OFD Biopharma, LLC in Albany, Oregon (FEI 3022538) after an inspection that ran Jun 27 – Jul 1, 2022. The investigators were Rowena S. Nguyen and Sara H. Gabel. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures…
- 02
Written records of investigations into unexplained discrepancies do not always include…
- 03
Changes to written procedures are not drafted, reviewed and approved by…
This inspection in context
Rowena S. Nguyen
12 documents · 2022–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in California.
The firmOFD Biopharma, LLC history
The site's inspection history, in date order.
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 OFD Biopharma, LLC?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected OFD Biopharma, LLC?
Rowena S. Nguyen and Sara H. Gabel are named on this Form 483, for the inspection of Jun 27 – Jul 1, 2022. Each investigator has a profile showing what they cite most.
When was OFD Biopharma, LLC inspected by FDA?
The inspection ran Jun 27 – Jul 1, 2022, and the Form 483 is dated July 1, 2022.
How do I get the full Form 483 for OFD Biopharma, LLC?
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.