Julianne C. McCullough
FDA investigator · also recorded as Eae Julianne McCullough, Ofs Julianne McCullough
Appears on 4 documents from 2010 to 2019, mostly at sites in Pennsylvania. Most often cites production record review (21 CFR 211.192).
- 4
- Documents on file
- 8.0
- Observations per 483
- 2010
- First seen
- 2019
- Most recent
What they cite most
From 24 observations- 21 CFR 211.192Production record review4
- 21 CFR 211.160General requirements3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.42(a)Design and construction features2
- 21 CFR 211.67Equipment cleaning and maintenance2
Activity by year
2010: 1, 2013: 1, 2015: 1, 2019: 1
Where
Pennsylvania 3 · Belgium 1
Often inspects with
Anita R. Michael· Jeen S. Min· Ofthis Pla Julianne McCullough
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-09-27 | 483 Baxter SASep 27, 2019 · Lessines, Belgium | Lessines, Belgium | 9 | |
| 2015-06-25 | 483 Almac Pharma Services LLCJun 25, 2015 · Audubon, Pennsylvania | Audubon, Pennsylvania | 6 | |
| 2013-04-01 | 483 Pentec Health, Inc.Apr 1, 2013 · Boothwyn, Pennsylvania | Boothwyn, Pennsylvania | 9 | |
| 2010-02-02 | EIR McNeil Consumer HealthcareFeb 2, 2010 · Fort Washington, Pennsylvania | Fort Washington, Pennsylvania | — |
About this profile
What does Julianne C. McCullough inspect?
Julianne C. McCullough appears on 4 documents on file covering 4 sites, mostly in Pennsylvania.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.160 and 21 CFR 211.100.
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 Julianne C. McCullough is dated Sep 27, 2019.