Frank J. Marciniak
FDA investigator
Appears on 7 documents from 2018 to 2023, mostly at sites in New Jersey. Most often cites design controls (21 CFR 820.30).
- 7
- Documents on file
- 4.9
- Observations per 483
- 2018
- First seen
- 2023
- Most recent
What they cite most
From 34 observations- 21 CFR 820.30Design controls8
- 21 CFR 820.100Corrective and preventive action5
- 21 CFR 820.75Process validation4
- 21 CFR 820.40Document controls3
- 21 CFR 820.184Device history record2
- 21 CFR 820.50Purchasing controls2
Activity by year
2018: 1, 2019: 2, 2021: 1, 2022: 1, 2023: 2
Where
New Jersey 6 · North Carolina 1
Often inspects with
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Inspection history
7 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-12-01 | 483 Howmedica Osteonics CorpDec 1, 2023 · Mahwah, New Jersey | Mahwah, New Jersey | 1 | |
| 2023-06-29 | 483 Navinta LLCJun 29, 2023 · Ewing, New Jersey | Ewing, New Jersey | 5 | |
| 2022-08-16 | 483 Alkaline CorporationAug 16, 2022 · Eatontown, New Jersey | Eatontown, New Jersey | 2 | |
| 2021-06-14 | 483 Svelte Medical SystemsJun 14, 2021 · New Providence, New Jersey | New Providence, New Jersey | 2 | |
| 2019-08-15 | 483 Water-Jel Technologies, LLCAug 15, 2019 · Huntersville, North Carolina | Huntersville, North Carolina | 11 | |
| 2019-06-14 | 483 LifeCell Corporation, A Wholly OwnedJun 14, 2019 · Branchburg, New Jersey | Branchburg, New Jersey | 4 | |
| 2018-10-03 | 483 Datascope CorpOct 3, 2018 · Mahwah, New Jersey | Mahwah, New Jersey | 9 |
About this profile
What does Frank J. Marciniak inspect?
Frank J. Marciniak appears on 7 documents on file covering 7 sites, mostly in New Jersey.
What do they cite most often?
21 CFR 820.30 (design controls), followed by 21 CFR 820.100 and 21 CFR 820.75.
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 Frank J. Marciniak is dated Dec 1, 2023.