Spectrum Laboratory Products, Inc.
FDA inspection history across 2 sites, 2016 to 2023
- 3
- Form 483s
- 2
- Close-outs
Every document, by year
- Form 483
- Close-out
2016: one Form 483; 2019: one close-out letter and one Form 483; 2021: one close-out letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at New Brunswick, New Jersey.
- 2019–23Two close-out letters and two Form 483s, at Gardena, California and New Brunswick, New Jersey.
- 2023The longest 483 on file: 14 observations over 14 pages at New Brunswick, New Jersey.
Cited most
Across all Spectrum Laboratory Products observations on file
- 21 CFR 211.194Laboratory records5
- 21 CFR 211.160General requirements4
- 21 CFR 211.192Production record review3
- 21 CFR 211.198Complaint files2
- 21 CFR 211.22Responsibilities of quality control unit2
The complete Spectrum Laboratory Products file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
New Brunswick, New Jersey
Three Form 483s · 2016 to 2023 · 24 observations
Latest: Form 483, Mar 24, 2023 →Gardena, California
Two close-out letters · 2019 to 2021
Latest: Close-out, Jun 24, 2021 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-03-24 | 483 Form 483 | New Brunswick, New Jersey | 14 | $99 |
| 2021-06-24 | Close-out Close-out letter | Gardena, California | — | $99 |
| 2019-07-31 | Close-out Close-out letter | Gardena, California | — | $99 |
| 2019-03-12 | 483 Form 483 | New Brunswick, New Jersey | 2 | $99 |
| 2016-03-14 | 483 Form 483 | New Brunswick, New Jersey | 8 | $99 |
Investigators on these documents
FEI number 2246824 · most recent document Mar 24, 2023
About Spectrum Laboratory Products, Inc.
How many FDA Form 483s has Spectrum Laboratory Products, Inc. received?
FDA Intel has 3 Form 483s on file for Spectrum Laboratory Products, Inc.; the most recent is dated Mar 24, 2023.
When was Spectrum Laboratory Products, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Spectrum Laboratory Products, Inc. is a Form 483 dated Mar 24, 2023, for the site in New Brunswick, New Jersey.
What did FDA cite at Spectrum Laboratory Products, Inc.?
The regulations cited most in the observations on file for Spectrum Laboratory Products, Inc. are 21 CFR 211.194 (Laboratory records), 5 times; 21 CFR 211.160 (General requirements), 4 times; 21 CFR 211.192 (Production record review), 3 times.