AstraZeneca Pharmaceuticals LP
Form 483 issued July 22, 2022 · Philadelphia, Pennsylvania
- Inspection
- Jul 11 – Jul 22, 2022
- Investigator
- Unnee Ranjan
- Observations
- 3
- Pages
- 4
- FEI number
- 3004829714
In short: On July 22, 2022, FDA issued a Form 483 with 3 observations to AstraZeneca Pharmaceuticals LP in Philadelphia, Pennsylvania (FEI 3004829714) after an inspection that ran Jul 11 – Jul 22, 2022. The investigator was Unnee Ranjan. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Investigations of an unexplained discrepancy did not extend to other batches of…
This inspection in context
Unnee Ranjan
30 documents · 2015–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in India.
The firmAstraZeneca Pharmaceuticals LP history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AstraZeneca Pharmaceuticals LP?
FDA listed 3 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected AstraZeneca Pharmaceuticals LP?
Unnee Ranjan is named on this Form 483, for the inspection of Jul 11 – Jul 22, 2022. Each investigator has a profile showing what they cite most.
When was AstraZeneca Pharmaceuticals LP inspected by FDA?
The inspection ran Jul 11 – Jul 22, 2022, and the Form 483 is dated July 22, 2022.
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.