Lonza Biologics, Inc.
Form 483 issued June 6, 2025 · Portsmouth, New Hampshire
- Investigators
- Kinjal Patel· Massoud Motamed· Timothy Kamaldinov
- Observations
- 10
- Pages
- 8
- FEI number
- 3001451441
In short: On June 6, 2025, FDA issued a Form 483 with 10 observations to Lonza Biologics, Inc. in Portsmouth, New Hampshire (FEI 3001451441). The investigators were Kinjal Patel, Massoud Motamed, Timothy Kamaldinov and Xiuju Lu.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing of CASGEVY drug prodiict is deficient. Through review…
- 02
Cleaning of Grade areas used in the manufacture of CASGEVY…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Heating, ventilation, and air conditioning maintenance…
This inspection in context
Questions about this 483
What did FDA find at Lonza Biologics, Inc.?
FDA listed 10 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Lonza Biologics, Inc.?
Kinjal Patel, Massoud Motamed, Timothy Kamaldinov and Xiuju Lu 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 June 6, 2025.
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.