Wyeth Pharmaceutical Division of Wyeth Holdings LLC
Form 483 issued October 17, 2024 · Sanford, North Carolina
- Inspection
- Oct 9 – Oct 17, 2024
- Investigators
- Burnell M. Henry· Unnee Ranjan
- Observations
- 1
- Pages
- 3
- FEI number
- 1000110954
In short: On October 17, 2024, FDA issued a Form 483 with 1 observation to Wyeth Pharmaceutical Division of Wyeth Holdings LLC in Sanford, North Carolina (FEI 1000110954) after an inspection that ran Oct 9 – Oct 17, 2024. The investigators were Burnell M. Henry and Unnee Ranjan. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (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 a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Burnell M. Henry
22 documents · 2012–2026
Cites 211.192 (production record review) 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 211.192
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 quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Wyeth Pharmaceutical Division of Wyeth Holdings LLC?
Burnell M. Henry and Unnee Ranjan are named on this Form 483, for the inspection of Oct 9 – Oct 17, 2024. Each investigator has a profile showing what they cite most.
When was Wyeth Pharmaceutical Division of Wyeth Holdings LLC inspected by FDA?
The inspection ran Oct 9 – Oct 17, 2024, and the Form 483 is dated October 17, 2024.
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.