Avista Pharma Solutions, Inc. dba
Form 483 issued December 18, 2019 · Agawam, Massachusetts
- Inspection
- Dec 9 – Dec 18, 2019
- Investigators
- John P. Mistler· Jonah S. Ufferfilge
- Observations
- 2
- Pages
- 3
- FEI number
- 1220785
In short: On December 18, 2019, FDA issued a Form 483 with 2 observations to Avista Pharma Solutions, Inc. dba in Agawam, Massachusetts (FEI 1220785) after an inspection that ran Dec 9 – Dec 18, 2019. The investigators were John P. Mistler and Jonah S. Ufferfilge. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.67(a) (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
John P. Mistler
15 documents · 2015–2023
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Massachusetts.
The firmAvista Pharma Solutions, Inc. dba history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Avista Pharma Solutions, Inc. dba?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Avista Pharma Solutions, Inc. dba?
John P. Mistler and Jonah S. Ufferfilge are named on this Form 483, for the inspection of Dec 9 – Dec 18, 2019. Each investigator has a profile showing what they cite most.
When was Avista Pharma Solutions, Inc. dba inspected by FDA?
The inspection ran Dec 9 – Dec 18, 2019, and the Form 483 is dated December 18, 2019.
How do I get the full Form 483 for Avista Pharma Solutions, Inc. dba?
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.