American Cleaning Solutions
Form 483 issued October 14, 2016 · Long Island City, New York
- Inspection
- Oct 3 – Oct 14, 2016
- Investigator
- Mindy M. Chou
- Observations
- 20
- Pages
- 8
- FEI number
- 3001587133
In short: On October 14, 2016, FDA issued a Form 483 with 20 observations to American Cleaning Solutions in Long Island City, New York (FEI 3001587133) after an inspection that ran Oct 3 – Oct 14, 2016. The investigator was Mindy M. Chou. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Drug products failing to meet established…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Employees are not given training in current good manufacturing practices and written procedures required by current…
This inspection in context
Mindy M. Chou
37 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) 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 211.165(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Cleaning Solutions?
FDA listed 20 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected American Cleaning Solutions?
Mindy M. Chou is named on this Form 483, for the inspection of Oct 3 – Oct 14, 2016. Each investigator has a profile showing what they cite most.
When was American Cleaning Solutions inspected by FDA?
The inspection ran Oct 3 – Oct 14, 2016, and the Form 483 is dated October 14, 2016.
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.