Barbara J. Wilimczyk-Macri
FDA investigator
Appears on 5 documents from 2012 to 2016, mostly at sites in New Jersey. Most often cites design and construction features (21 CFR 211.42).
- 5
- Documents on file
- 11.0
- Observations per 483
- 2012
- First seen
- 2016
- Most recent
What they cite most
From 55 observations- 21 CFR 211.42Design and construction features11
- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.192Production record review4
- 21 CFR 211.194Laboratory records4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.166Stability testing3
Activity by year
2012: 1, 2013: 1, 2015: 2, 2016: 1
Where
New Jersey 5
Often inspects with
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Inspection history
5 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2016-04-04 | 483 Akorn Operating Company LLC (dba Akorn)Apr 4, 2016 · Somerset, New Jersey | Somerset, New Jersey | 12 | |
| 2015-07-13 | 483 PharMEDium Services, LLCJul 13, 2015 · Edison, New Jersey | Edison, New Jersey | 10 | |
| 2015-05-22 | 483 Liberty Drug & SurgicalMay 22, 2015 · Chatham, New Jersey | Chatham, New Jersey | 13 | |
| 2013-04-03 | 483 MedPREP Consulting Inc.Apr 3, 2013 · Tinton Falls, New Jersey | Tinton Falls, New Jersey | 13 | |
| 2012-07-30 | 483 Integra LifeSciences CorporationJul 30, 2012 · Plainsboro, New Jersey | Plainsboro, New Jersey | 7 |
About this profile
What does Barbara J. Wilimczyk-Macri inspect?
Barbara J. Wilimczyk-Macri appears on 5 documents on file covering 5 sites, mostly in New Jersey.
What do they cite most often?
21 CFR 211.42 (design and construction features), followed by 21 CFR 211.113 and 21 CFR 211.192.
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 Barbara J. Wilimczyk-Macri is dated Apr 4, 2016.