Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
Form 483 issued April 28, 2017 · Andover, Massachusetts
- Inspection
- Apr 17 – Apr 28, 2017
- Investigator
- Debra M. Emerson
- Observations
- 4
- Pages
- 2
- FEI number
- 1222181
In short: On April 28, 2017, FDA issued a Form 483 with 4 observations to Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC in Andover, Massachusetts (FEI 1222181) after an inspection that ran Apr 17 – Apr 28, 2017. The investigator was Debra M. Emerson. Most observations concern biologics CGMP and production; the most-cited regulation is 21 CFR 600.11 (physical establishment, equipment, animals, and care).
At a glance
Biologics CGMP and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The filling of the Benefix drug substance occurs within (9) ©) area. There is inadequate space…
- 02
The procedure: Operation of Balances…
- 03
The program for the requalification of equipment is an assessment which is…
- 04
In 2014, the manufacture of the 1 liter) (9) used to store Benefix bulk drug substance…
This inspection in context
Debra M. Emerson
27 documents · 2008–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmWyeth BioPharma Division of Wyeth Pharmaceuticals LLC history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 600.11
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC?
FDA listed 4 observations on this Form 483, mostly about biologics CGMP, production and facilities & equipment. The most-cited regulation is 21 CFR 600.11 (physical establishment, equipment, animals, and care). The opening words of each observation are shown on this page.
Who inspected Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC?
Debra M. Emerson is named on this Form 483, for the inspection of Apr 17 – Apr 28, 2017. Each investigator has a profile showing what they cite most.
When was Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC inspected by FDA?
The inspection ran Apr 17 – Apr 28, 2017, and the Form 483 is dated April 28, 2017.
How do I get the full Form 483 for Wyeth BioPharma Division of Wyeth Pharmaceuticals 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.