AstraZeneca Pharmaceuticals LP
Form 483 issued February 26, 2016 · Redwood City, California
- Inspection
- Feb 16 – Feb 26, 2016
- Investigators
- Ashar P. Parikh· Gk Lisa K. Capron· Lisa K. Capron
- Observations
- 6
- Pages
- 6
- FEI number
- 3011389428
In short: On February 26, 2016, FDA issued a Form 483 with 6 observations to AstraZeneca Pharmaceuticals LP in Redwood City, California (FEI 3011389428) after an inspection that ran Feb 16 – Feb 26, 2016. The investigators were Ashar P. Parikh, Gk Lisa K. Capron and Lisa K. Capron. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.22 (2×) · 211.28 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm's quality control unit is deficient as observed during the…
- 02
Your firm's label control…
- 03
Your firm's employee practices…
- 04
Your quality assurance unit failed to adequately review certificates of…
This inspection in context
Ashar P. Parikh
19 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmAstraZeneca Pharmaceuticals LP history
The site's inspection history, in date order.
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?
FDA listed 6 observations on this Form 483, mostly about production, quality system and packaging & labeling. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected AstraZeneca Pharmaceuticals LP?
Ashar P. Parikh, Gk Lisa K. Capron and Lisa K. Capron are named on this Form 483, for the inspection of Feb 16 – Feb 26, 2016. Each investigator has a profile showing what they cite most.
When was AstraZeneca Pharmaceuticals LP inspected by FDA?
The inspection ran Feb 16 – Feb 26, 2016, and the Form 483 is dated February 26, 2016.
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.