Lauren N. Smith
FDA investigator
Appears on 3 documents from 2015 to 2016, mostly at sites in Ohio. Most often cites responsibilities of quality control unit (21 CFR 211.22).
- 3
- Documents on file
- 5.3
- Observations per 483
- 2015
- First seen
- 2016
- Most recent
What they cite most
From 16 observations- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.166(a)Stability testing2
- 21 CFR 211.192Production record review2
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.188(b)(12)Batch production and control records1
Activity by year
2015: 1, 2016: 2
Where
Ohio 2 · Kentucky 1
Often inspects with
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2016-09-06 | 483 Woodbine Products Co IncSep 6, 2016 · Medina, Ohio | Medina, Ohio | 7 | |
| 2016-03-11 | 483 Patheon Pharmaceuticals IncMar 11, 2016 · Cincinnati, Ohio | Cincinnati, Ohio | 2 | |
| 2015-10-16 | 483 Best Sanitizers, IncOct 16, 2015 · Walton, Kentucky | Walton, Kentucky | 7 |
About this profile
What does Lauren N. Smith inspect?
Lauren N. Smith appears on 3 documents on file covering 3 sites, mostly in Ohio.
What do they cite most often?
21 CFR 211.22 (responsibilities of quality control unit), followed by 21 CFR 211.100(a) and 21 CFR 211.166(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 Lauren N. Smith is dated Sep 6, 2016.