Shanghai Plumino Amino Acid Co.,Ltd.
Form 483 issued December 15, 2023 · Shanghai, China
- Investigator
- Wayne D. McGrath
- Observations
- 1
- Pages
- 1
- FEI number
- 3005253125
In short: On December 15, 2023, FDA issued a Form 483 with 1 observation to Shanghai Plumino Amino Acid Co.,Ltd. in Shanghai, China (FEI 3005253125). The investigator was Wayne D. McGrath. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written production and process control procedures are not followed in the execution of production and process…
This inspection in context
Wayne D. McGrath
33 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmShanghai Plumino Amino Acid Co.,Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shanghai Plumino Amino Acid Co.,Ltd.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Shanghai Plumino Amino Acid Co.,Ltd.?
Wayne D. McGrath is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Shanghai Plumino Amino Acid Co.,Ltd. inspected by FDA?
This Form 483 is dated December 15, 2023.
How do I get the full Form 483 for Shanghai Plumino Amino Acid Co.,Ltd.?
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.