Form 483 · FEI 3009685660
Form 483 issued April 28, 2023 · Warszawa, Poland
- Inspection
- Apr 17 – Apr 28, 2023
- Investigators
- Anastasia M. Shields· Xiaokuang Lai
- Observations
- 3
- Pages
- 3
- FEI number
- 3009685660
In short: On April 28, 2023, FDA issued a Form 483 with 3 observations to an FDA-inspected site in Warszawa, Mazowieckie (FEI 3009685660) after an inspection that ran Apr 17 – Apr 28, 2023. The investigators were Anastasia M. Shields and Xiaokuang Lai. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Employees engaged in the manufacture, processing and packing of a drug product lack the education and…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.25
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 3 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Anastasia M. Shields and Xiaokuang Lai are named on this Form 483, for the inspection of Apr 17 – Apr 28, 2023. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Apr 17 – Apr 28, 2023, and the Form 483 is dated April 28, 2023.
How do I get the full Form 483 for an FDA-inspected site?
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.