The Skin Atelier, Inc
Form 483 issued April 4, 2019 · Goshen, New York
- Inspection
- Mar 28 – Apr 4, 2019
- Investigator
- Sony Mathews
- Observations
- 9
- Pages
- 10
- FEI number
- 3005976760
In short: On April 4, 2019, FDA issued a Form 483 with 9 observations to The Skin Atelier, Inc in Goshen, New York (FEI 3005976760) after an inspection that ran Mar 28 – Apr 4, 2019. The investigator was Sony Mathews. Most observations concern production and packaging & labeling.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Drug product expiration dates are not related to the storage conditions stated on the labeling, as…
- 04
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Sony Mathews
22 documents · 2010–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmThe Skin Atelier, Inc 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(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The Skin Atelier, Inc?
FDA listed 9 observations on this Form 483, mostly about production, packaging & labeling and laboratory controls. The opening words of each observation are shown on this page.
Who inspected The Skin Atelier, Inc?
Sony Mathews is named on this Form 483, for the inspection of Mar 28 – Apr 4, 2019. Each investigator has a profile showing what they cite most.
When was The Skin Atelier, Inc inspected by FDA?
The inspection ran Mar 28 – Apr 4, 2019, and the Form 483 is dated April 4, 2019.
How do I get the full Form 483 for The Skin Atelier, Inc?
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.