Spectrum Laboratory Products, Inc.
Form 483 issued March 12, 2019 · New Brunswick, New Jersey
- Inspection
- Feb 19 – Mar 8, 2019
- Investigator
- Emmanuel J. Ramos
- Observations
- 2
- Pages
- 2
- FEI number
- 2246824
In short: On March 12, 2019, FDA issued a Form 483 with 2 observations to Spectrum Laboratory Products, Inc. in New Brunswick, New Jersey (FEI 2246824) after an inspection that ran Feb 19 – Mar 8, 2019. The investigator was Emmanuel J. Ramos.
What FDA observed
Preview: the opening words of each observation- 01
Failure to ensure requirements…
- 02
Failure to ensure requirements…
This inspection in context
Emmanuel J. Ramos
9 documents · 2017–2021
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmSpectrum Laboratory Products, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Spectrum Laboratory Products, Inc.?
FDA listed 2 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Spectrum Laboratory Products, Inc.?
Emmanuel J. Ramos is named on this Form 483, for the inspection of Feb 19 – Mar 8, 2019. Each investigator has a profile showing what they cite most.
When was Spectrum Laboratory Products, Inc. inspected by FDA?
The inspection ran Feb 19 – Mar 8, 2019, and the Form 483 is dated March 12, 2019.
How do I get the full Form 483 for Spectrum Laboratory Products, 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.