Caroline H. Le
FDA investigator
Appears on 6 documents from 2008 to 2011, mostly at sites in Michigan. Most often cites production record review (21 CFR 211.192).
- 6
- Documents on file
- 11.3
- Observations per 483
- 2008
- First seen
- 2011
- Most recent
What they cite most
From 34 observations- 21 CFR 211.192Production record review6
- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.101Charge-in of components3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.188Batch production and control records2
Activity by year
2008: 4, 2009: 1, 2011: 1
Where
Michigan 5 · Utah 1
Often inspects with
Is Caroline H. Le coming to your site?
Our team writes custom reports before an inspection: what this investigator cites most, how they write it up, and how your site's history compares, in one brief you can circulate.
Ask about any investigator in Claude or ChatGPT with the AI connector.
Inspection history
6 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2011-03-11 | 483 Wasatch Product Development, LLCMar 11, 2011 · Draper, Utah | Draper, Utah | 10 | |
| 2009-06-05 | EIR Caraco Pharmaceutical Laboratories, Ltd.Jun 5, 2009 · Wixom, Michigan | Wixom, Michigan | — | |
| 2008-11-07 | 483 L. Perrigo CoNov 7, 2008 · Allegan, Michigan | Allegan, Michigan | 10 | |
| 2008-10-01 | EIR L. Perrigo CoOct 1, 2008 · Allegan, Michigan | Allegan, Michigan | — | |
| 2008-06-11 | 483 Caraco Pharmaceutical Laboratories, Ltd.Jun 11, 2008 · Detroit, Michigan | Detroit, Michigan | 14 | |
| 2008-01-29 | EIR Aunt Mid's Produce CompanyJan 29, 2008 · Detroit, Michigan | Detroit, Michigan | — |
About this profile
What does Caroline H. Le inspect?
Caroline H. Le appears on 6 documents on file covering 5 sites, mostly in Michigan.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.100 and 21 CFR 211.22.
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 Caroline H. Le is dated Mar 11, 2011.