Lonza Walkersville, Inc
Form 483 issued February 6, 2017 · Walkersville, Maryland
- Inspection
- Jan 18 – Feb 6, 2017
- Investigator
- Marc S. Neubauer
- Observations
- 10
- Pages
- 13
- FEI number
- 1114298
In short: On February 6, 2017, FDA issued a Form 483 with 10 observations to Lonza Walkersville, Inc in Walkersville, Maryland (FEI 1114298) after an inspection that ran Jan 18 – Feb 6, 2017. The investigator was Marc S. Neubauer. Most observations concern production & process controls and management controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
Production & process controls and management controls account for 7 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 0121 CFR 820.20(b)21 CFR 820
The organizational structure has not been adequately established and maintained to ensure that devices are produced…
- 02
Personnel do not have the necessary training…
- 03
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 04
Process control procedures that describe any process controls necessary to ensure conformance to specifications…
This inspection in context
Marc S. Neubauer
3 documents · 2011–2017
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Maryland.
The firmLonza Walkersville, 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 820.20(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lonza Walkersville, Inc?
FDA listed 10 observations on this Form 483, mostly about production & process controls, management controls and cAPA. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Lonza Walkersville, Inc?
Marc S. Neubauer is named on this Form 483, for the inspection of Jan 18 – Feb 6, 2017. Each investigator has a profile showing what they cite most.
When was Lonza Walkersville, Inc inspected by FDA?
The inspection ran Jan 18 – Feb 6, 2017, and the Form 483 is dated February 6, 2017.
How do I get the full Form 483 for Lonza Walkersville, 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.