MassBiologics
Form 483 issued July 21, 2010 · Boston, Massachusetts
- Inspection
- Jul 13 – Jul 21, 2010
- Investigator
- Prabhu P. Raju
- Observations
- 8
- Pages
- 5
- FEI number
- 3003058218
In short: On July 21, 2010, FDA issued a Form 483 with 8 observations to MassBiologics in Boston, Massachusetts (FEI 3003058218) after an inspection that ran Jul 13 – Jul 21, 2010. The investigator was Prabhu P. Raju. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 1 system, led by quality system.
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 visual inspection results is…
- 03
The following written records for Product Complaint (PC) investigations did…
- 04
The following procedures do not…
This inspection in context
Prabhu P. Raju
21 documents · 2008–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in France.
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 8 observations on this Form 483, mostly about 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?
Prabhu P. Raju is named on this Form 483, for the inspection of Jul 13 – Jul 21, 2010. Each investigator has a profile showing what they cite most.
When was MassBiologics inspected by FDA?
The inspection ran Jul 13 – Jul 21, 2010, and the Form 483 is dated July 21, 2010.
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.