Amphastar Nanjing Pharmaceuticals
Form 483 issued October 11, 2019 · Nanjing, China
- Investigator
- Angela E. Glenn
- Observations
- 1
- Pages
- 1
- FEI number
- 3009805706
In short: On October 11, 2019, FDA issued a Form 483 with 1 observation to Amphastar Nanjing Pharmaceuticals in Nanjing, Jiangsu (FEI 3009805706). The investigator was Angela E. Glenn. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.170 (reserve samples).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.170 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
This inspection in context
Angela E. Glenn
10 documents · 2016–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmAmphastar Nanjing Pharmaceuticals history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.170
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amphastar Nanjing Pharmaceuticals?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.170 (reserve samples). The opening words of each observation are shown on this page.
Who inspected Amphastar Nanjing Pharmaceuticals?
Angela E. Glenn is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Amphastar Nanjing Pharmaceuticals inspected by FDA?
This Form 483 is dated October 11, 2019.
How do I get the full Form 483 for Amphastar Nanjing Pharmaceuticals?
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.