AstraZeneca Pharmaceuticals LP
Form 483 issued May 31, 2024 · Gaithersburg, Maryland
- Inspection
- May 20 – May 31, 2024
- Investigators
- Ekaterina Allen· James R. Birkenstamm· Jazmine N. Brown
- Observations
- 4
- Pages
- 8
- FEI number
- 1000198729
In short: On May 31, 2024, FDA issued a Form 483 with 4 observations to AstraZeneca Pharmaceuticals LP in Gaithersburg, Maryland (FEI 1000198729) after an inspection that ran May 20 – May 31, 2024. The investigators were Ekaterina Allen, James R. Birkenstamm and Jazmine N. Brown. Most observations concern quality system and laboratory controls.
At a glance
3 of 4 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Laboratory records are deficient in that they do not include a complete record of all…
- 03
The responsibilities and procediues applicable to the quality control unit are not in…
- 04
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Ekaterina Allen
6 documents · 2021–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Italy.
The firmAstraZeneca Pharmaceuticals LP history
The site's inspection history, in date order.
Similar 483sOther 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?
FDA listed 4 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected AstraZeneca Pharmaceuticals LP?
Ekaterina Allen, James R. Birkenstamm and Jazmine N. Brown are named on this Form 483, for the inspection of May 20 – May 31, 2024. Each investigator has a profile showing what they cite most.
When was AstraZeneca Pharmaceuticals LP inspected by FDA?
The inspection ran May 20 – May 31, 2024, and the Form 483 is dated May 31, 2024.
How do I get the full Form 483 for AstraZeneca Pharmaceuticals LP?
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.