Clean Solutions LLC
Form 483 issued May 10, 2024 · Clifton, New Jersey
- Inspection
- May 6 – May 10, 2024
- Investigators
- Catherine O. Lamptey· Olumide A. Akinyemi· Vivin George
- Observations
- 9
- Pages
- 9
- FEI number
- 3012305678
In short: On May 10, 2024, FDA issued a Form 483 with 9 observations to Clean Solutions LLC in Clifton, New Jersey (FEI 3012305678) after an inspection that ran May 6 – May 10, 2024. The investigators were Catherine O. Lamptey, Olumide A. Akinyemi and Vivin George. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Drug product component testing is deficient in that at least one specific test to verify the…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Yom firm failed to establish written procedures for production and process controls designed to assure that…
- 04
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Catherine O. Lamptey
3 documents · 2024–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New Jersey.
The firmClean Solutions LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(d)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Clean Solutions LLC?
FDA listed 9 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Clean Solutions LLC?
Catherine O. Lamptey, Olumide A. Akinyemi and Vivin George are named on this Form 483, for the inspection of May 6 – May 10, 2024. Each investigator has a profile showing what they cite most.
When was Clean Solutions LLC inspected by FDA?
The inspection ran May 6 – May 10, 2024, and the Form 483 is dated May 10, 2024.
How do I get the full Form 483 for Clean Solutions LLC?
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.