ProCaire, Limited Liability Company
Form 483 issued May 17, 2019 · Plainville, Massachusetts
- Inspection
- May 13 – May 17, 2019
- Investigators
- Jonah S. Ufferfilge· Jonathan G. Matrisciano
- Observations
- 6
- Pages
- 7
- FEI number
- 3014721008
In short: On May 17, 2019, FDA issued a Form 483 with 6 observations to ProCaire, Limited Liability Company in Plainville, Massachusetts (FEI 3014721008) after an inspection that ran May 13 – May 17, 2019. The investigators were Jonah S. Ufferfilge and Jonathan G. Matrisciano. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
4 of 6 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
The separate or defined areas necessary to prevent contamination…
- 04
Routine calibration of mechanical and electronic equipment is not performed according to a written program designed…
This inspection in context
Jonah S. Ufferfilge
17 documents · 2019–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Connecticut.
The firmProCaire, Limited Liability Company 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 ProCaire, Limited Liability Company?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected ProCaire, Limited Liability Company?
Jonah S. Ufferfilge and Jonathan G. Matrisciano are named on this Form 483, for the inspection of May 13 – May 17, 2019. Each investigator has a profile showing what they cite most.
When was ProCaire, Limited Liability Company inspected by FDA?
The inspection ran May 13 – May 17, 2019, and the Form 483 is dated May 17, 2019.
How do I get the full Form 483 for ProCaire, Limited Liability Company?
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