Spectrum Laboratory Products, Inc.
Form 483 issued March 24, 2023 · New Brunswick, New Jersey
- Inspection
- Feb 17 – Mar 24, 2023
- Investigator
- Sawem H. Akbar
- Observations
- 14
- Pages
- 14
- FEI number
- 2246824
In short: On March 24, 2023, FDA issued a Form 483 with 14 observations to Spectrum Laboratory Products, Inc. in New Brunswick, New Jersey (FEI 2246824) after an inspection that ran Feb 17 – Mar 24, 2023. The investigator was Sawem H. Akbar. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 9 of 14 observations.
Most cited: 21 CFR 211.192 (2×) · 211.194 (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 conduct repackaging operations under appropriate environmental conditions to…
- 02
Cleaning procedures are not…
- 03
There is a lack of defined areas or other control systems for…
- 04
Written procedures are not established and followed for investigating critical deviations or the failure of a…
This inspection in context
Sawem H. Akbar
1 document · 2023
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.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Spectrum Laboratory Products, Inc.?
FDA listed 14 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Spectrum Laboratory Products, Inc.?
Sawem H. Akbar is named on this Form 483, for the inspection of Feb 17 – Mar 24, 2023. Each investigator has a profile showing what they cite most.
When was Spectrum Laboratory Products, Inc. inspected by FDA?
The inspection ran Feb 17 – Mar 24, 2023, and the Form 483 is dated March 24, 2023.
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.