Oxford Pharmaceuticals, LLC
Form 483 issued May 22, 2019 · Birmingham, Alabama
- Inspection
- May 14 – May 22, 2019
- Investigator
- Francis Guidry
- Observations
- 3
- Pages
- 4
- FEI number
- 3012257735
In short: On May 22, 2019, FDA issued a Form 483 with 3 observations to Oxford Pharmaceuticals, LLC in Birmingham, Alabama (FEI 3012257735) after an inspection that ran May 14 – May 22, 2019. The investigator was Francis Guidry. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 03
Deviations from written specification, and test…
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 firmOxford Pharmaceuticals, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Oxford Pharmaceuticals, LLC?
FDA listed 3 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 Oxford Pharmaceuticals, LLC?
Francis Guidry is named on this Form 483, for the inspection of May 14 – May 22, 2019. Each investigator has a profile showing what they cite most.
When was Oxford Pharmaceuticals, LLC inspected by FDA?
The inspection ran May 14 – May 22, 2019, and the Form 483 is dated May 22, 2019.
How do I get the full Form 483 for Oxford Pharmaceuticals, 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.