Elizabeth A. Krolczyk
FDA investigator
Appears on 6 documents from 2024 to 2026, mostly at sites in Texas. Most often cites design controls (21 CFR 820.30(a)).
- 6
- Documents on file
- 5.5
- Observations per 483
- 2024
- First seen
- 2026
- Most recent
What they cite most
From 33 observations- 21 CFR 820.30(a)Design controls8
- 21 CFR 820.70Production and process controls3
- 21 CFR 8202
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 820.198(a)Complaint files2
- 21 CFR 820.25(b)Personnel2
Activity by year
2024: 2, 2025: 3, 2026: 1
Where
Texas 5 · New Jersey 1
Often inspects with
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Inspection history
6 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-02-11 | 483 Turnco Tool & Instrument, IncFeb 11, 2026 · Georgetown, Texas | Georgetown, Texas | 2 | |
| 2025-05-16 | 483 Blue Elephant IncMay 16, 2025 · Southlake, Texas | Southlake, Texas | 9 | |
| 2025-05-09 | 483 Smaart Medical Systems, IncMay 9, 2025 · Dallas, Texas | Dallas, Texas | 13 | |
| 2025-04-07 | 483 Cetylite Industries, Inc.Apr 7, 2025 · Pennsauken, New Jersey | Pennsauken, New Jersey | 2 | |
| 2024-12-16 | 483 Swiss-American CDMO, LLCDec 16, 2024 · Carrollton, Texas | Carrollton, Texas | 2 | |
| 2024-10-07 | 483 Brius Technologies IncOct 7, 2024 · Carrollton, Texas | Carrollton, Texas | 5 |
About this profile
What does Elizabeth A. Krolczyk inspect?
Elizabeth A. Krolczyk appears on 6 documents on file covering 6 sites, mostly in Texas.
What do they cite most often?
21 CFR 820.30(a) (design controls), followed by 21 CFR 820.70 and 21 CFR 820.
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Elizabeth A. Krolczyk is dated Feb 11, 2026.