Staska Phaimaceuticals, fuc
Form 483 issued September 26, 2024 · Bennet, Nebraska
- Inspection
- Sep 3 – Sep 18, 2024
- Investigator
- Lisa L. Flores
- Observations
- 9
- Pages
- 9
- FEI number
- 3017473850
In short: On September 26, 2024, FDA issued a Form 483 with 9 observations to Staska Phaimaceuticals, fuc in Bennet, Nebraska (FEI 3017473850) after an inspection that ran Sep 3 – Sep 18, 2024. The investigator was Lisa L. Flores. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Your fnm failed to establish acceptance criteria for the sampling and testing conducted by the quality…
- 03
Employees engaged in the manufacture and processing of a drug product lack the training required to…
- 04
Aseptic processing areas ai·e deficient regai·ding the system…
This inspection in context
Lisa L. Flores
20 documents · 2012–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmStaska Phaimaceuticals, fuc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Staska Phaimaceuticals, fuc?
FDA listed 9 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Staska Phaimaceuticals, fuc?
Lisa L. Flores is named on this Form 483, for the inspection of Sep 3 – Sep 18, 2024. Each investigator has a profile showing what they cite most.
When was Staska Phaimaceuticals, fuc inspected by FDA?
The inspection ran Sep 3 – Sep 18, 2024, and the Form 483 is dated September 26, 2024.
How do I get the full Form 483 for Staska Phaimaceuticals, fuc?
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.