Wendy R. Blame
FDA investigator
Appears on 2 documents from 2017 to 2019, mostly at sites in Alabama. Most often cites what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me? (21 CFR 803.17).
- 2
- Documents on file
- 7.5
- Observations per 483
- 2017
- First seen
- 2019
- Most recent
What they cite most
From 15 observations- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?2
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 820.181Device master record2
- 21 CFR 820.184Device history record2
- 21 CFR 820.198(a)Complaint files2
- 21 CFR 820.50Purchasing controls2
Activity by year
2017: 1, 2019: 1
Where
Alabama 2
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Inspection history
2 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-08-23 | 483 Health Science Products IncAug 23, 2019 · Hueytown, Alabama | Hueytown, Alabama | 8 | |
| 2017-10-30 | 483 Health Science Products IncOct 30, 2017 · Hueytown, Alabama | Hueytown, Alabama | 7 |
About this profile
What does Wendy R. Blame inspect?
Wendy R. Blame appears on 2 documents on file covering 1 site, mostly in Alabama.
What do they cite most often?
21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), followed by 21 CFR 820.100(a) and 21 CFR 820.181.
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 Wendy R. Blame is dated Aug 23, 2019.