Pharmasol Corporation
Form 483 issued February 10, 2022 · South Easton, Massachusetts
- Inspection
- Jan 10 – Feb 10, 2022
- Investigators
- Leanna M. Slarsky· Sean R. Marcsisin
- Observations
- 9
- Pages
- 15
- FEI number
- 1250001
In short: On February 10, 2022, FDA issued a Form 483 with 9 observations to Pharmasol Corporation in South Easton, Massachusetts (FEI 1250001) after an inspection that ran Jan 10 – Feb 10, 2022. The investigators were Leanna M. Slarsky and Sean R. Marcsisin. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 7 of 9 observations.
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 whether or not the batch…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Procedures describing the handling of written and oral complaints related to drug products are…
- 04
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
This inspection in context
Leanna M. Slarsky
3 documents · 2021–2022
Cites FDCA 501(a)(2)(A) (insanitary conditions) 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, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Pharmasol Corporation?
Leanna M. Slarsky and Sean R. Marcsisin are named on this Form 483, for the inspection of Jan 10 – Feb 10, 2022. Each investigator has a profile showing what they cite most.
When was Pharmasol Corporation inspected by FDA?
The inspection ran Jan 10 – Feb 10, 2022, and the Form 483 is dated February 10, 2022.
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.