Wyeth Pharmaceutical Division of Wyeth Holdings LLC
Form 483 issued November 10, 2023 · Sanford, North Carolina
- Investigators
- Jianyang Wang· Kevin Makhens· Pestis Fietle
- Observations
- 1
- Pages
- 1
- FEI number
- 1000110954
In short: On November 10, 2023, FDA issued a Form 483 with 1 observation to Wyeth Pharmaceutical Division of Wyeth Holdings LLC in Sanford, North Carolina (FEI 1000110954). The investigators were Jianyang Wang, Kevin Makhens, Pestis Fietle and Ronit Jolles-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 nol) Nrest on the incoming starting material (b) (4) 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 firmWyeth Pharmaceutical Division of Wyeth Holdings LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
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 Wyeth Pharmaceutical Division of Wyeth Holdings LLC?
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 Wyeth Pharmaceutical Division of Wyeth Holdings LLC?
Jianyang Wang, Kevin Makhens, Pestis Fietle and Ronit Jolles-Mazor are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Wyeth Pharmaceutical Division of Wyeth Holdings LLC inspected by FDA?
This Form 483 is dated November 10, 2023.
How do I get the full Form 483 for Wyeth Pharmaceutical Division of Wyeth Holdings 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.