AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente
Form 483 issued January 19, 2023 · Frederick, Maryland
- Inspection
- Jan 9 – Jan 19, 2023
- Investigators
- Anastasia M. Shields· Sena G. Dissmeyer
- Observations
- 2
- Pages
- 4
- FEI number
- 3002617771
In short: On January 19, 2023, FDA issued a Form 483 with 2 observations to AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente in Frederick, Maryland (FEI 3002617771) after an inspection that ran Jan 9 – Jan 19, 2023. The investigators were Anastasia M. Shields and Sena G. Dissmeyer. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.68 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
The use of sporicidal agents in the ISO 5 classified…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmAstraZeneca 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 483sOther sites cited under 211.68
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 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente?
Anastasia M. Shields and Sena G. Dissmeyer are named on this Form 483, for the inspection of Jan 9 – Jan 19, 2023. Each investigator has a profile showing what they cite most.
When was AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente inspected by FDA?
The inspection ran Jan 9 – Jan 19, 2023, and the Form 483 is dated January 19, 2023.
How do I get the full Form 483 for AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente?
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