AstraZeneca Pharmaceuticals LP
Form 483 issued September 19, 2023 · Mount Vernon, Indiana
- Inspection
- Sep 11 – Sep 19, 2023
- Investigator
- Joseph A. Piechocki
- Observations
- 2
- Pages
- 3
- FEI number
- 1825662
In short: On September 19, 2023, FDA issued a Form 483 with 2 observations to AstraZeneca Pharmaceuticals LP in Mount Vernon, Indiana (FEI 1825662) after an inspection that ran Sep 11 – Sep 19, 2023. The investigator was Joseph A. Piechocki. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.110(a) (1×) · 211.194(a)(4) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not followed that describe the in-process controls to be conducted on appropriate samples…
- 02
Laboratory records are deficient in that they do not include a complete record of all…
This inspection in context
Joseph A. Piechocki
19 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAstraZeneca Pharmaceuticals LP history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AstraZeneca Pharmaceuticals LP?
FDA listed 2 observations on this Form 483, mostly about production and laboratory controls. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected AstraZeneca Pharmaceuticals LP?
Joseph A. Piechocki is named on this Form 483, for the inspection of Sep 11 – Sep 19, 2023. Each investigator has a profile showing what they cite most.
When was AstraZeneca Pharmaceuticals LP inspected by FDA?
The inspection ran Sep 11 – Sep 19, 2023, and the Form 483 is dated September 19, 2023.
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.