FDA Form 483 Pfizer, Sanford, NC Nov 2023
Form 483 issued November 10, 2023 · Sanford, North Carolina
- Inspection
- Nov 6 – Nov 10, 2023
- Investigators
- Jianyang Wang· Jie He· Kevin Matthews
- Observations
- 1
- Pages
- 1
- FEI number
- 000110954
In short: On November 10, 2023, FDA issued a Form 483 with 1 observation to FDA Form 483 Pfizer, Sanford, NC Nov 2023 in Sanford, North Carolina (FEI 000110954) after an inspection that ran Nov 6 – Nov 10, 2023. The investigators were Jianyang Wang, Jie He, Kevin Matthews and Ronit Iolles-Mazor. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no (b) (4 test on the incoming starting material ( D used for the…
This inspection in context
Jianyang Wang
3 documents · 2022–2023
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in North Carolina.
The firmFDA Form 483 Pfizer, Sanford, NC Nov 2023 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FDA Form 483 Pfizer, Sanford, NC Nov 2023?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected FDA Form 483 Pfizer, Sanford, NC Nov 2023?
Jianyang Wang, Jie He, Kevin Matthews and Ronit Iolles-Mazor are named on this Form 483, for the inspection of Nov 6 – Nov 10, 2023. Each investigator has a profile showing what they cite most.
When was FDA Form 483 Pfizer, Sanford, NC Nov 2023 inspected by FDA?
The inspection ran Nov 6 – Nov 10, 2023, and the Form 483 is dated November 10, 2023.
How do I get the full Form 483 for FDA Form 483 Pfizer, Sanford, NC Nov 2023?
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.