Curia Massachusetts, Inc.
Form 483 issued May 24, 2017 · Burlington, Massachusetts
- Inspection
- May 15 – May 24, 2017
- Investigator
- Jonathan G. Matrisciano
- Observations
- 2
- Pages
- 3
- FEI number
- 3002951540
In short: On May 24, 2017, FDA issued a Form 483 with 2 observations to Curia Massachusetts, Inc. in Burlington, Massachusetts (FEI 3002951540) after an inspection that ran May 15 – May 24, 2017. The investigator was Jonathan G. Matrisciano. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.22 (1×)
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…
- 02
The responsibilities and procedures applicable to the quality control unit…
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 firmCuria Massachusetts, 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 Curia Massachusetts, Inc.?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Curia Massachusetts, Inc.?
Jonathan G. Matrisciano is named on this Form 483, for the inspection of May 15 – May 24, 2017. Each investigator has a profile showing what they cite most.
When was Curia Massachusetts, Inc. inspected by FDA?
The inspection ran May 15 – May 24, 2017, and the Form 483 is dated May 24, 2017.
How do I get the full Form 483 for Curia Massachusetts, 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.