Wyeth Pharmaceutical Division of Wyeth Holdings LLC
Form 483 issued November 18, 2022 · Sanford, North Carolina
- Inspection
- Nov 9 – Nov 18, 2022
- Investigators
- Burnell M. Henry· Lewis K. Antwi
- Observations
- 2
- Pages
- 3
- FEI number
- 1000110954
In short: On November 18, 2022, FDA issued a Form 483 with 2 observations to Wyeth Pharmaceutical Division of Wyeth Holdings LLC in Sanford, North Carolina (FEI 1000110954) after an inspection that ran Nov 9 – Nov 18, 2022. The investigators were Burnell M. Henry and Lewis K. Antwi. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do…
- 02
Water for injection, (b)(4), and swab samples are not bracketed between standard solutions in the analytical…
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 211.160
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 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Wyeth Pharmaceutical Division of Wyeth Holdings LLC?
Burnell M. Henry and Lewis K. Antwi are named on this Form 483, for the inspection of Nov 9 – Nov 18, 2022. 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 Nov 9 – Nov 18, 2022, and the Form 483 is dated November 18, 2022.
How do I get the full Form 483 for Wyeth Pharmaceutical Division of Wyeth Holdings LLC?
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