MassBiologics
Form 483 issued September 1, 2022 · Boston, Massachusetts
- Inspection
- Aug 23 – Sep 1, 2022
- Investigator
- Roger F. Zabinski
- Observations
- 3
- Pages
- 4
- FEI number
- 3003058218
In short: On September 1, 2022, FDA issued a Form 483 with 3 observations to MassBiologics in Boston, Massachusetts (FEI 3003058218) after an inspection that ran Aug 23 – Sep 1, 2022. The investigator was Roger F. Zabinski. Most observations concern facilities & equipment and production.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Manufacturing procedures designed to prevent microbiological contamination of drug products and medial purporting to be sterile…
- 02
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the…
- 03
Buildings, facilities, and equipment used in the manufacturing, processing, and holding of drug products and samples…
This inspection in context
Roger F. Zabinski
36 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MassBiologics?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected MassBiologics?
Roger F. Zabinski is named on this Form 483, for the inspection of Aug 23 – Sep 1, 2022. Each investigator has a profile showing what they cite most.
When was MassBiologics inspected by FDA?
The inspection ran Aug 23 – Sep 1, 2022, and the Form 483 is dated September 1, 2022.
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.