LONZA WALKERSVILLE, INC. — FDA Facility Profile
LONZA WALKERSVILLE, INC. is an FDA-registered facility (FEI 1114298) located in WALKERSVILLE, MD, US. RegDataLab tracks 11 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Mar 24, 2026: No Action Indicated (NAI)
- Inspections on record
- 11 (1 OAI, 6 VAI, 4 NAI)
- Last OAI inspection
- Feb 6, 2017
- Warning letters
- 1 listed by FDA for this FEI, latest Apr 21, 2017
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 24, 2026 | No Action Indicated (NAI) | No citations listed |
| Nov 5, 2021 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Contamination control, Lack of or inadequate procedures (21 CFR 820.70(e)) Lack/Inad procedure-Monitoring/Control of Validated Proces (21 CFR 820.75(b)) Lack of or inadequate procedures (21 CFR 820.100(a)) and 2 more |
| Jul 26, 2018 | Voluntary Action Indicated (VAI) | No citations listed |
| Jul 3, 2018 | No Action Indicated (NAI) | Lack of or inadequate procedures (21 CFR 820.100(a)) Calibration, Inspection, etc. Procedures Lack of or Inadequ (21 CFR 820.72(a)) Process control procedures, Lack of or inadequate procedures (21 CFR 820.70(a)) Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50) |
| Feb 6, 2017 | Official Action Indicated (OAI) | Lack/Inad procedure-Monitoring/Control of Validated Proces (21 CFR 820.75(b)) Lack of or inadequate procedures (21 CFR 820.100(a)) Lack of or inadequate procedures for handling (21 CFR 820.140) Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a)) and 6 more |
| Jun 9, 2016 | Voluntary Action Indicated (VAI) | No citations listed |
| Aug 13, 2013 | Voluntary Action Indicated (VAI) | No citations listed |
| Dec 2, 2011 | Voluntary Action Indicated (VAI) | Lack/Inad procedure-Monitoring/Control of Validated Proces (21 CFR 820.75(b)) Storage procedures to avoid release of unsuitable product (21 CFR 820.150(a)) Identification of actions needed (21 CFR 820.100(a)(3)) Lack of procedures, or not maintained (21 CFR 820.40) and 4 more |
| Aug 23, 2011 | No Action Indicated (NAI) | No citations listed |
| Dec 17, 2009 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Lonza Walkersville, Inc.
- Location
- WALKERSVILLE, MD (US)
- Source
- device