Pharmasol Corporation
Form 483 issued August 20, 2018 · South Easton, Massachusetts
- Inspection
- Jul 23 – Aug 20, 2018
- Investigators
- Jonathan G. Matrisciano· Sean R. Marcsisin
- Observations
- 9
- Pages
- 16
- FEI number
- 1250001
In short: On August 20, 2018, FDA issued a Form 483 with 9 observations to Pharmasol Corporation in South Easton, Massachusetts (FEI 1250001) after an inspection that ran Jul 23 – Aug 20, 2018. The investigators were Jonathan G. Matrisciano and Sean R. Marcsisin. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit are not fully followed. This is…
- 03
The results and/or dates of management…
- 04
The written stability testing…
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 firmPharmasol Corporation history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmasol Corporation?
FDA listed 9 observations on this Form 483, mostly about quality system, facilities & equipment and management controls. The opening words of each observation are shown on this page.
Who inspected Pharmasol Corporation?
Jonathan G. Matrisciano and Sean R. Marcsisin are named on this Form 483, for the inspection of Jul 23 – Aug 20, 2018. Each investigator has a profile showing what they cite most.
When was Pharmasol Corporation inspected by FDA?
The inspection ran Jul 23 – Aug 20, 2018, and the Form 483 is dated August 20, 2018.
How do I get the full Form 483 for Pharmasol Corporation?
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.