ENGLEWOOD LAB, INC.
Form 483 issued April 23, 2025 · TOTOWA, New Jersey
- Inspection
- Apr 14 – Apr 23, 2025
- Investigators
- Luxuly Abraham· Rose Jean-Mary
- Observations
- 4
- Pages
- 5
- FEI number
- 3013020160
In short: On April 23, 2025, FDA issued a Form 483 with 4 observations to ENGLEWOOD LAB, INC. in TOTOWA, New Jersey (FEI 3013020160) after an inspection that ran Apr 14 – Apr 23, 2025. The investigators were Luxuly Abraham and Rose Jean-Mary. Most observations concern materials and production.
At a glance
Observations span 4 systems, led by materials.
What FDA observed
Preview: the opening words of each observation- 01
Specific identification tests are not conducted on components that have been accepted based on the…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and…
This inspection in context
Luxuly Abraham
7 documents · 2023–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
The firmENGLEWOOD LAB, INC. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ENGLEWOOD LAB, INC.?
FDA listed 4 observations on this Form 483, mostly about materials, production and quality system. The opening words of each observation are shown on this page.
Who inspected ENGLEWOOD LAB, INC.?
Luxuly Abraham and Rose Jean-Mary are named on this Form 483, for the inspection of Apr 14 – Apr 23, 2025. Each investigator has a profile showing what they cite most.
When was ENGLEWOOD LAB, INC. inspected by FDA?
The inspection ran Apr 14 – Apr 23, 2025, and the Form 483 is dated April 23, 2025.
How do I get the full Form 483 for ENGLEWOOD LAB, 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.