American Cleaning Solutions
Form 483 issued March 28, 2022 · Long Island City, New York
- Inspection
- Mar 7 – Mar 28, 2022
- Investigators
- Bijoy Panicker· Vivin George
- Observations
- 18
- Pages
- 12
- FEI number
- 3001587133
In short: On March 28, 2022, FDA issued a Form 483 with 18 observations to American Cleaning Solutions in Long Island City, New York (FEI 3001587133) after an inspection that ran Mar 7 – Mar 28, 2022. The investigators were Bijoy Panicker and Vivin George. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Deviations from written production and process control proced lues are i…
- 02
Drug products failing to meet established…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
All records of distribution associated with a batch of drug product were not maintained at least…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmAmerican Cleaning Solutions history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Cleaning Solutions?
FDA listed 18 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected American Cleaning Solutions?
Bijoy Panicker and Vivin George are named on this Form 483, for the inspection of Mar 7 – Mar 28, 2022. Each investigator has a profile showing what they cite most.
When was American Cleaning Solutions inspected by FDA?
The inspection ran Mar 7 – Mar 28, 2022, and the Form 483 is dated March 28, 2022.
How do I get the full Form 483 for American Cleaning Solutions?
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.