MassBiologics
Form 483 issued May 24, 2012 · Boston, Massachusetts
- Inspection
- May 16 – May 24, 2012
- Investigators
- James Keller· Leslie Wagner· Susan M. Jackson
- Observations
- 5
- Pages
- 3
- FEI number
- 3003058218
In short: On May 24, 2012, FDA issued a Form 483 with 5 observations to MassBiologics in Boston, Massachusetts (FEI 3003058218) after an inspection that ran May 16 – May 24, 2012. The investigators were James Keller, Leslie Wagner and Susan M. Jackson. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
The root cause assigned to Deviation ID-09-126…
- 03
Deviation…
- 04
There is no written procedure requiring that all filling operators work in the aseptic operation of…
This inspection in context
James Keller
1 document · 2012
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Massachusetts.
The firmMassBiologics history
All 4 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 MassBiologics?
FDA listed 5 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected MassBiologics?
James Keller, Leslie Wagner and Susan M. Jackson are named on this Form 483, for the inspection of May 16 – May 24, 2012. Each investigator has a profile showing what they cite most.
When was MassBiologics inspected by FDA?
The inspection ran May 16 – May 24, 2012, and the Form 483 is dated May 24, 2012.
How do I get the full Form 483 for MassBiologics?
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.