FDA Intel

Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC

Form 483 issued July 23, 2021 · Andover, Massachusetts

Inspection
Jul 23, 2021
Investigators
Anissa M. Cheung· Debra M. Emerson· Ekaterina Allen
Observations
13
Pages
5
FEI number
1222181

In short: On July 23, 2021, FDA issued a Form 483 with 13 observations to Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC in Andover, Massachusetts (FEI 1222181) after an inspection that ran Jul 23, 2021. The investigators were Anissa M. Cheung, Debra M. Emerson, Ekaterina Allen and Kathleen R. Jones. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

8 of 13 observations on this 483 concern facilities & equipment.

Facilities & equipment8
Quality system3
Production1
Materials1

Most cited: 21 CFR 211.42 (4×) · 211.192 (2×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    21 CFR 211.192

    Observation 1: scanned text, readable in the full document.

  2. 02
    21 CFR 211.2221 CFR 211.188

    There is inadequate quality…

  3. 03
    21 CFR 211.192

    Observation 3: scanned text, readable in the full document.

  4. 04
    21 CFR 211.67

    Observation 4: scanned text, readable in the full document.

9 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Anissa M. Cheung

7 documents · 2017–2024

Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.

The firm

Wyeth 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 483s

Other sites cited under 211.42

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 13 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.

Who inspected Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC?

Anissa M. Cheung, Debra M. Emerson, Ekaterina Allen and Kathleen R. Jones are named on this Form 483, for the inspection of Jul 23, 2021. 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 Jul 23, 2021, and the Form 483 is dated July 23, 2021.

How do I get the full Form 483 for Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC?

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