Lonza Biologics, Inc.
Form 483 issued October 22, 2021 · Portsmouth, New Hampshire
- Investigators
- Debra M. Emerson· Obinna Echeozo
- Observations
- 4
- Pages
- 3
- FEI number
- 3001451441
In short: On October 22, 2021, FDA issued a Form 483 with 4 observations to Lonza Biologics, Inc. in Portsmouth, New Hampshire (FEI 3001451441). The investigators were Debra M. Emerson and Obinna Echeozo. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations into deviations are not always initiated in a timely manner. There were multiple instances, where…
- 02
Human errors that occur during validation are documented as comments and not handled…
- 03
The manufacturing, storage, and utility areas are not kept clean and free from dust, dirt, vermin…
- 04
The facility is not maintained in a state of control in that leaking pipes and equipment…
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 firmLonza Biologics, Inc. history
All 7 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 Lonza Biologics, Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Lonza Biologics, Inc.?
Debra M. Emerson and Obinna Echeozo are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Lonza Biologics, Inc. inspected by FDA?
This Form 483 is dated October 22, 2021.
How do I get the full Form 483 for Lonza Biologics, Inc.?
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.