AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente
Form 483 issued March 19, 2021 · Frederick, Maryland
- Investigators
- Meense Viviana Matta· Viviana Matta· Zhao Wang
- Observations
- 3
- Pages
- 4
- FEI number
- 3002617771
In short: On March 19, 2021, FDA issued a Form 483 with 3 observations to AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente in Frederick, Maryland (FEI 3002617771). The investigators were Meense Viviana Matta, Viviana Matta and Zhao Wang. Most observations concern quality system and production.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities of the quality control unit are not in…
- 02
Your firm has failed to establish adequate microbial control for®®…
- 03
Your firm has failed to thoroughly investigate deviations/nonconformities and OOS results to ensure its investigations identify…
This inspection in context
Meense Viviana Matta
1 document · 2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Maryland.
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 211.22
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 3 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente?
Meense Viviana Matta, Viviana Matta and Zhao Wang are named on this Form 483. Each investigator has a profile showing what they cite most.
When was AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente inspected by FDA?
This Form 483 is dated March 19, 2021.
How do I get the full Form 483 for AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente?
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.