Oxford Pharmaceuticals, LLC
Form 483 issued November 3, 2023 · Birmingham, Alabama
- Investigators
- Martrice A. Packer· Marvin D. Jones
- Observations
- 4
- Pages
- 4
- FEI number
- 3012257735
In short: On November 3, 2023, FDA issued a Form 483 with 4 observations to Oxford Pharmaceuticals, LLC in Birmingham, Alabama (FEI 3012257735). The investigators were Martrice A. Packer and Marvin D. Jones. Most observations concern facilities & equipment and quality system.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 02
The quality control unit lacks authority to fully investigate…
- 03
Time limits are not established when appropriate for the completion of each production phase to assure…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
Martrice A. Packer
6 documents · 2022–2024
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Alabama.
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 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Oxford Pharmaceuticals, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Oxford Pharmaceuticals, LLC?
Martrice A. Packer and Marvin D. Jones are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Oxford Pharmaceuticals, LLC inspected by FDA?
This Form 483 is dated November 3, 2023.
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.