Loretta Nemchik
FDA investigator
Appears on 3 documents from 2002 to 2012, mostly at sites in New Jersey. Most often cites production and process controls (21 CFR 820.70(c)).
- 3
- Documents on file
- 7.5
- Observations per 483
- 2002
- First seen
- 2012
- Most recent
What they cite most
From 15 observations- 21 CFR 820.70(c)Production and process controls5
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 820.90(a)Nonconforming product2
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 803.56If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?1
- 21 CFR 820.150Storage1
Activity by year
2002: 1, 2011: 1, 2012: 1
Where
New Jersey 3
Often inspects with
Meredith L. Sheridan· Barbara J. Wilimczyk-Macri· Shirley Isbill
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2012-07-30 | 483 Integra LifeSciences CorporationJul 30, 2012 · Plainsboro, New Jersey | Plainsboro, New Jersey | 7 | |
| 2011-08-25 | 483 Integra LifeSciences CorpAug 25, 2011 · Plainsbo ro, New Jersey | Plainsbo ro, New Jersey | 8 | |
| 2002-06-05 | Warning letter Comprehensive Clinical ResearchJun 5, 2002 · Berlin, New Jersey | Berlin, New Jersey | — |
About this profile
What does Loretta Nemchik inspect?
Loretta Nemchik appears on 3 documents on file covering 1 site, mostly in New Jersey.
What do they cite most often?
21 CFR 820.70(c) (production and process controls), followed by 21 CFR 820.100(a) and 21 CFR 820.90(a).
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 Loretta Nemchik is dated Jul 30, 2012.