Phoenix Wipes Inc
Form 483 issued December 19, 2023 · West Babylon, New York
- Inspection
- Dec 4 – Dec 19, 2023
- Investigator
- Vivin George
- Observations
- 9
- Pages
- 6
- FEI number
- 3017229738
In short: On December 19, 2023, FDA issued a Form 483 with 9 observations to Phoenix Wipes Inc in West Babylon, New York (FEI 3017229738) after an inspection that ran Dec 4 – Dec 19, 2023. The investigator was Vivin George. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.180 (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
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Drug product component testing is deficient in that at least one specific test to verify the…
- 04
Your firm failed to establish written procedures for production and process controls designed to assure that…
This inspection in context
Vivin George
20 documents · 2019–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New York.
The firmPhoenix Wipes Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.180
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Phoenix Wipes Inc?
FDA listed 9 observations on this Form 483, mostly about quality system, materials and production. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Phoenix Wipes Inc?
Vivin George is named on this Form 483, for the inspection of Dec 4 – Dec 19, 2023. Each investigator has a profile showing what they cite most.
When was Phoenix Wipes Inc inspected by FDA?
The inspection ran Dec 4 – Dec 19, 2023, and the Form 483 is dated December 19, 2023.
How do I get the full Form 483 for Phoenix Wipes Inc?
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.