AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente
FDA inspection history in Frederick, Maryland, 2021 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–24Three Form 483s, at Frederick, Maryland.
- 2024The longest 483 on file: 4 observations over 2 pages at Frederick, Maryland.
Cited most
Across all AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Frederick, Maryland
Three Form 483s · 2021 to 2024 · 9 observations
Latest: Form 483, Jun 7, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-07 | 483 Form 483 | Frederick, Maryland | 4 | $99 |
| 2023-01-19 | 483 Form 483 | Frederick, Maryland | 2 | $99 |
| 2021-03-19 | 483 Form 483 | Frederick, Maryland | 3 | $99 |
Investigators on these documents
Anastasia M. Shields (1)Christina Farris (1)Kristen Nickens (1)Liqun Zhao (1)Meense Viviana Matta (1)Sena G. Dissmeyer (1)Vidya B. Pai (1)Viviana Matta (1)Wayne Seifert (1)Zhao Wang (1)
FEI number 3002617771 · most recent document Jun 7, 2024
About AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente
How many FDA Form 483s has AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente received?
FDA Intel has 3 Form 483s on file for AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente; the most recent is dated Jun 7, 2024.
When was AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente last inspected by FDA?
The most recent FDA inspection document on file for AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente is a Form 483 dated Jun 7, 2024, for the site in Frederick, Maryland.
What did FDA cite at AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente?
The regulations cited most in the observations on file for AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times.