Porton Pharma Solutions Ltd

FDA inspection history in Changshou, China, 2018

1
Form 483

Every document, by year

  • Form 483

2018: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2018One Form 483, at Changshou, China.

Cited most

Across all Porton Pharma Solutions observations on file

The complete Porton Pharma Solutions file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2018-11-23483 Form 483$99

Investigators on these documents

Arsen Karapetyan (1)

FEI number 3006625990 · most recent document Nov 23, 2018

About Porton Pharma Solutions Ltd

How many FDA Form 483s has Porton Pharma Solutions Ltd received?

FDA Intel has 1 Form 483 on file for Porton Pharma Solutions Ltd; the most recent is dated Nov 23, 2018.

When was Porton Pharma Solutions Ltd last inspected by FDA?

The most recent FDA inspection document on file for Porton Pharma Solutions Ltd is a Form 483 dated Nov 23, 2018, for the site in Changshou, China.

What did FDA cite at Porton Pharma Solutions Ltd?

The regulations cited most in the observations on file for Porton Pharma Solutions Ltd are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 1 time.