James A. Lane
FDA investigator
Appears on 2 documents from 2011 to 2019, mostly at sites in Indiana. Most often cites recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan (21 CFR 118.10).
- 2
- Documents on file
- 3.5
- Observations per 483
- 2011
- First seen
- 2019
- Most recent
What they cite most
From 7 observations- 21 CFR 118.10Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan1
- 21 CFR 118.4Salmonella Enteritidis (SE) prevention measures1
- 21 CFR 803.52(b)(2)If I am a manufacturer, what information must I submit in my individual adverse event reports?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.30(f)Design controls1
- 21 CFR 820.50(a)(1)Purchasing controls1
Activity by year
2011: 1, 2019: 1
Where
Indiana 1 · Washington 1
Often inspects with
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Inspection history
2 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-11-26 | 483 Physio-Control, IncNov 26, 2019 · Redmond, Washington | Redmond, Washington | 5 | |
| 2011-04-12 | 483 Jay EggApr 12, 2011 · Portland, Indiana | Portland, Indiana | 2 |
About this profile
What does James A. Lane inspect?
James A. Lane appears on 2 documents on file covering 2 sites, mostly in Indiana.
What do they cite most often?
21 CFR 118.10 (recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan), followed by 21 CFR 118.4 and 21 CFR 803.52(b)(2).
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 James A. Lane is dated Nov 26, 2019.