AIDANCE SCIENTIFIC INC DBA AIDANCE SKINCARE & TOPICAL SOLUTIONS
Form 483 issued February 12, 2025 · Woonsocket, Rhode Island
- Inspection
- Feb 3 – Feb 12, 2025
- Investigator
- Jonathan G. Matrisciano
- Observations
- 4
- Pages
- 4
- FEI number
- 3006613129
In short: On February 12, 2025, FDA issued a Form 483 with 4 observations to AIDANCE SCIENTIFIC INC DBA AIDANCE SKINCARE & TOPICAL SOLUTIONS in Woonsocket, Rhode Island (FEI 3006613129) after an inspection that ran Feb 3 – Feb 12, 2025. The investigator was Jonathan G. Matrisciano. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would. alter the…
- 03
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
- 04
Written records of major equipment cleaning, maintenance and use are not included…
This inspection in context
Jonathan G. Matrisciano
29 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmAIDANCE SCIENTIFIC INC DBA AIDANCE SKINCARE & TOPICAL SOLUTIONS history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AIDANCE SCIENTIFIC INC DBA AIDANCE SKINCARE & TOPICAL SOLUTIONS?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected AIDANCE SCIENTIFIC INC DBA AIDANCE SKINCARE & TOPICAL SOLUTIONS?
Jonathan G. Matrisciano is named on this Form 483, for the inspection of Feb 3 – Feb 12, 2025. Each investigator has a profile showing what they cite most.
When was AIDANCE SCIENTIFIC INC DBA AIDANCE SKINCARE & TOPICAL SOLUTIONS inspected by FDA?
The inspection ran Feb 3 – Feb 12, 2025, and the Form 483 is dated February 12, 2025.
How do I get the full Form 483 for AIDANCE SCIENTIFIC INC DBA AIDANCE SKINCARE & TOPICAL 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.