Lonza Houston, Inc.
Form 483 issued December 10, 2020 · Houston, Texas
- Inspection
- Dec 3 – Dec 10, 2020
- Investigators
- Lauren M. Lilly· Scott Ballard· Steven E. Bowen
- Observations
- 4
- Pages
- 8
- FEI number
- 3013629214
In short: On December 10, 2020, FDA issued a Form 483 with 4 observations to Lonza Houston, Inc. in Houston, Texas (FEI 3013629214) after an inspection that ran Dec 3 – Dec 10, 2020. The investigators were Lauren M. Lilly, Scott Ballard and Steven E. Bowen. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment 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
Physical and electronic control of material storage…
- 02
The identity of each incoming batch of certain raw…
- 03
Written procedures are not…
- 04
Microbial contamination controls are…
This inspection in context
Lauren M. Lilly
5 documents · 2020–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmLonza Houston, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lonza Houston, Inc.?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Lonza Houston, Inc.?
Lauren M. Lilly, Scott Ballard and Steven E. Bowen are named on this Form 483, for the inspection of Dec 3 – Dec 10, 2020. Each investigator has a profile showing what they cite most.
When was Lonza Houston, Inc. inspected by FDA?
The inspection ran Dec 3 – Dec 10, 2020, and the Form 483 is dated December 10, 2020.
How do I get the full Form 483 for Lonza Houston, 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.