Porton Pharma Solutions Ltd
Form 483 issued November 23, 2018 · Changshou, China
- Investigator
- Arsen Karapetyan
- Observations
- 3
- Pages
- 5
- FEI number
- 3006625990
In short: On November 23, 2018, FDA issued a Form 483 with 3 observations to Porton Pharma Solutions Ltd in Changshou, Chongqing (FEI 3006625990). The investigator was Arsen Karapetyan. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
3 of 3 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Supervisory oversight over laboratory investigations with respect to the laboratory electronic systems…
- 03
Written records of investigations into unexplained discrepancies are not always initiated and do not always…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmPorton Pharma Solutions Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Porton Pharma Solutions Ltd?
FDA listed 3 observations on this Form 483, mostly about quality system. 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 Porton Pharma Solutions Ltd?
Arsen Karapetyan is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Porton Pharma Solutions Ltd inspected by FDA?
This Form 483 is dated November 23, 2018.
How do I get the full Form 483 for Porton Pharma Solutions 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.