FDA Intel

AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente

Form 483 issued June 7, 2024 · Frederick, Maryland

Inspection
May 30 – Jun 7, 2024
Investigators
Christina Farris· Kristen Nickens· Liqun Zhao
Observations
4
Pages
2
FEI number
3002617771

In short: On June 7, 2024, FDA issued a Form 483 with 4 observations to AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente in Frederick, Maryland (FEI 3002617771) after an inspection that ran May 30 – Jun 7, 2024. The investigators were Christina Farris, Kristen Nickens, Liqun Zhao, Vidya B. Pai and Wayne Seifert. 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 4 of 4 observations.

Quality system2
Facilities & equipment2

Most cited: 21 CFR 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

    Drug substance upstream manufacturing systems have unmitigated risk in assurance of…

  2. 02
    21 CFR 211.6721 CFR 211.100

    Procedures in support of manufacture and the QC…

  3. 03
    21 CFR 211.192

    There is a failure to thoroughly document product quality…

  4. 04
    21 CFR 211.68

    Analytical instruments in support of manufacture are not adequately controlled in…

The full 483

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

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This inspection in context

The investigator

Christina Farris

1 document · 2024

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

The firm

AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente history

All 3 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.192

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente?

FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. 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 AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente?

Christina Farris, Kristen Nickens, Liqun Zhao, Vidya B. Pai and Wayne Seifert are named on this Form 483, for the inspection of May 30 – Jun 7, 2024. Each investigator has a profile showing what they cite most.

When was AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente inspected by FDA?

The inspection ran May 30 – Jun 7, 2024, and the Form 483 is dated June 7, 2024.

How do I get the full Form 483 for AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente?

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