Wyeth Pharmaceutical Division of Wyeth Holdings LLC
Form 483 issued November 26, 2019 · Sanford, North Carolina
- Inspection
- Nov 19 – Nov 26, 2019
- Investigators
- Brentley Collins· Jacqueline Diaz-Albertini· Scott E. Norris
- Observations
- 7
- Pages
- 7
- FEI number
- 1000110954
In short: On November 26, 2019, FDA issued a Form 483 with 7 observations to Wyeth Pharmaceutical Division of Wyeth Holdings LLC in Sanford, North Carolina (FEI 1000110954) after an inspection that ran Nov 19 – Nov 26, 2019. The investigators were Brentley Collins, Jacqueline Diaz-Albertini and Scott E. Norris. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 5 of 7 observations.
Most cited: 21 CFR 211.192 (2×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations are incomplete, lack documentation, and/or not assessed for impact on…
- 02
Lack of oversight by Quality Assurance for service providers contracted for the off-site storage of Master…
- 03
Initial valid Out of Specification results are not investigated at the…
- 04
No data to support that extended incubation times do not compromise or inhibit the recovery of…
This inspection in context
Brentley Collins
11 documents · 2019–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
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 7 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. 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?
Brentley Collins, Jacqueline Diaz-Albertini and Scott E. Norris are named on this Form 483, for the inspection of Nov 19 – Nov 26, 2019. 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 19 – Nov 26, 2019, and the Form 483 is dated November 26, 2019.
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.