MassBiologics
Form 483 issued November 19, 2019 · Boston, Massachusetts
- Inspection
- Jan 8 – Nov 19, 2019
- Investigators
- Debra M. Emerson· Janet L. Bowen· Leslie Wagner
- Observations
- 11
- Pages
- 7
- FEI number
- 3003058218
In short: On November 19, 2019, FDA issued a Form 483 with 11 observations to MassBiologics in Boston, Massachusetts (FEI 3003058218) after an inspection that ran Jan 8 – Nov 19, 2019. The investigators were Debra M. Emerson, Janet L. Bowen, Leslie Wagner, Lindsey Lyman and Susan M. Jackson. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (2×) · 211.188 (2×)
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 sterile did not include…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch…
- 04
The batch production and control records are deficient in that they do not include documentation of…
This inspection in context
Debra M. Emerson
27 documents · 2008–2022
Cites 211.113 (control of microbiological contamination) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MassBiologics?
FDA listed 11 observations on this Form 483, mostly about production, quality system and facilities & equipment. 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 MassBiologics?
Debra M. Emerson, Janet L. Bowen, Leslie Wagner, Lindsey Lyman and Susan M. Jackson are named on this Form 483, for the inspection of Jan 8 – Nov 19, 2019. Each investigator has a profile showing what they cite most.
When was MassBiologics inspected by FDA?
The inspection ran Jan 8 – Nov 19, 2019, and the Form 483 is dated November 19, 2019.
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.