NOXELL CORPORATION
Form 483 issued February 25, 2019 · HUNT VALLEY, Maryland
- Inspection
- Feb 14 – Feb 25, 2019
- Investigators
- Jaison J. Eapen· Sena G. Dissmeyer
- Observations
- 3
- Pages
- 2
- FEI number
- 1111567
In short: On February 25, 2019, FDA issued a Form 483 with 3 observations to NOXELL CORPORATION in HUNT VALLEY, Maryland (FEI 1111567) after an inspection that ran Feb 14 – Feb 25, 2019. The investigators were Jaison J. Eapen and Sena G. Dissmeyer. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
The batch production and control records are deficient in that they do not include documentation of…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
The persons double-checking the cleaning and maintenance are not dating and signing or initialing the equipment…
This inspection in context
Jaison J. Eapen
3 documents · 2019–2020
Cites 211.182 (equipment cleaning and use log) more than any other section. Most of their documents are for sites in Maryland.
The firmNOXELL CORPORATION history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.188(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at NOXELL CORPORATION?
FDA listed 3 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected NOXELL CORPORATION?
Jaison J. Eapen and Sena G. Dissmeyer are named on this Form 483, for the inspection of Feb 14 – Feb 25, 2019. Each investigator has a profile showing what they cite most.
When was NOXELL CORPORATION inspected by FDA?
The inspection ran Feb 14 – Feb 25, 2019, and the Form 483 is dated February 25, 2019.
How do I get the full Form 483 for NOXELL CORPORATION?
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.