MassBiologics
FDA inspection history in Boston, Massachusetts, 2010 to 2022
- 4
- Form 483s
Every document, by year
- Form 483
2010: one Form 483; 2012: one Form 483; 2019: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010–12Two Form 483s, at Boston, Massachusetts.
- 2019One Form 483, at Boston, Massachusetts.
- 2019The longest 483 on file: 11 observations over 7 pages at Boston, Massachusetts.
- 2022One Form 483, at Boston, Massachusetts.
Cited most
Across all MassBiologics observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.192Production record review3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.188Batch production and control records2
- 21 CFR 211.198Complaint files2
The complete MassBiologics file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Boston, Massachusetts
Four Form 483s · 2010 to 2022 · 26 observations
Latest: Form 483, Sep 1, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-01 | 483 Form 483 | Boston, Massachusetts | 3 | $99 |
| 2019-11-19 | 483 Form 483 | Boston, Massachusetts | 11 | $99 |
| 2012-05-24 | 483 Form 483 | Boston, Massachusetts | 4 | $99 |
| 2010-07-21 | 483 Form 483 | Boston, Massachusetts | 8 | $99 |
Investigators on these documents
Leslie Wagner (2)Susan M. Jackson (2)Janet L. Bowen (1)Debra M. Emerson (1)Prabhu P. Raju (1)Roger F. Zabinski (1)Lindsey Lyman (1)James Keller (1)
FEI number 3003058218 · most recent document Sep 1, 2022
About MassBiologics
How many FDA Form 483s has MassBiologics received?
FDA Intel has 4 Form 483s on file for MassBiologics; the most recent is dated Sep 1, 2022.
When was MassBiologics last inspected by FDA?
The most recent FDA inspection document on file for MassBiologics is a Form 483 dated Sep 1, 2022, for the site in Boston, Massachusetts.
What did FDA cite at MassBiologics?
The regulations cited most in the observations on file for MassBiologics are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times.