Lonza Walkersville, Inc
FDA inspection history across 2 sites, 2017
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2017: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One warning letter and one Form 483, at Basel, Switzerland and Walkersville, Maryland.
Cited most
Across all Lonza Walkersville observations on file
- 21 CFR 820.70(a)Production and process controls2
- 21 CFR 820.75(a)Process validation2
- 21 CFR 8201
- 21 CFR 807.22(b)(3)Times for establishment registration and device listing1
- 21 CFR 820.100(a)Corrective and preventive action1
The complete Lonza Walkersville file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Basel, Switzerland
One warning letter · 2017
Latest: Warning letter, Apr 21, 2017 →Walkersville, Maryland
One Form 483 · 2017 · 10 observations
Latest: Form 483, Feb 6, 2017 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-04-21 | Warning letter Warning letter | Basel, Switzerland | — | $99 |
| 2017-02-06 | 483 Form 483 | Walkersville, Maryland | 10 | $99 |
Investigators on these documents
FEI number 1114298 · most recent document Apr 21, 2017
About Lonza Walkersville, Inc
How many FDA Form 483s has Lonza Walkersville, Inc received?
FDA Intel has 1 Form 483 on file for Lonza Walkersville, Inc; the most recent is dated Feb 6, 2017.
When was Lonza Walkersville, Inc last inspected by FDA?
The most recent FDA inspection document on file for Lonza Walkersville, Inc is a Form 483 dated Feb 6, 2017, for the site in Walkersville, Maryland.
What did FDA cite at Lonza Walkersville, Inc?
The regulations cited most in the observations on file for Lonza Walkersville, Inc are 21 CFR 820.70(a) (Production and process controls), 2 times; 21 CFR 820.75(a) (Process validation), 2 times; 21 CFR 820, 1 time.
Has Lonza Walkersville, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Lonza Walkersville, Inc; the most recent is dated Apr 21, 2017.