Clean Solutions LLC
FDA inspection history in Clifton, New Jersey, 2024
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One warning letter and one Form 483, at Clifton, New Jersey.
Cited most
Across all Clean Solutions observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(b)Stability testing1
- 21 CFR 211.180(e)(1)General requirements1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
The complete Clean Solutions file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Clifton, New Jersey
One warning letter and one Form 483 · 2024 · 9 observations
Latest: Warning letter, Sep 6, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-09-06 | Warning letter Warning letter | Clifton, New Jersey | — | $99 |
| 2024-05-10 | 483 Form 483 | Clifton, New Jersey | 9 | $99 |
Investigators on these documents
Catherine O. Lamptey (1)Olumide A. Akinyemi (1)Vivin George (1)
FEI number 3012305678 · most recent document Sep 6, 2024
About Clean Solutions LLC
How many FDA Form 483s has Clean Solutions LLC received?
FDA Intel has 1 Form 483 on file for Clean Solutions LLC; the most recent is dated May 10, 2024.
When was Clean Solutions LLC last inspected by FDA?
The most recent FDA inspection document on file for Clean Solutions LLC is a Form 483 dated May 10, 2024, for the site in Clifton, New Jersey.
What did FDA cite at Clean Solutions LLC?
The regulations cited most in the observations on file for Clean Solutions LLC are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.165(a) (Testing and release for distribution), 1 time; 21 CFR 211.166(b) (Stability testing), 1 time.
Has Clean Solutions LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Clean Solutions LLC; the most recent is dated Sep 6, 2024.