Particle Sciences, Inc.
Form 483 issued June 24, 2021 · Bethlehem, Pennsylvania
- Inspection
- Jun 21 – Jun 24, 2021
- Investigator
- Viviana Matta
- Observations
- 4
- Pages
- 4
- FEI number
- 3003940898
In short: On June 24, 2021, FDA issued a Form 483 with 4 observations to Particle Sciences, Inc. in Bethlehem, Pennsylvania (FEI 3003940898) after an inspection that ran Jun 21 – Jun 24, 2021. The investigator was Viviana Matta. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Written records of investigations into unexplained discrepancies do not always include…
- 04
Written production and process control procedures are not followed in the execution of production and process…
This inspection in context
Viviana Matta
17 documents · 2012–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
The firmParticle Sciences, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Particle Sciences, Inc.?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Particle Sciences, Inc.?
Viviana Matta is named on this Form 483, for the inspection of Jun 21 – Jun 24, 2021. Each investigator has a profile showing what they cite most.
When was Particle Sciences, Inc. inspected by FDA?
The inspection ran Jun 21 – Jun 24, 2021, and the Form 483 is dated June 24, 2021.
How do I get the full Form 483 for Particle Sciences, 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.