Mary A. Millner
FDA investigator
Appears on 9 documents from 2015 to 2024, mostly at sites in Tennessee. Most often cites corrective and preventive action (21 CFR 820.100).
- 9
- Documents on file
- 6.4
- Observations per 483
- 2015
- First seen
- 2024
- Most recent
What they cite most
From 51 observations- 21 CFR 820.100Corrective and preventive action6
- 21 CFR 820.30(c)Design controls6
- 21 CFR 211.42(b)Design and construction features4
- 21 CFR 820.70(a)Production and process controls3
- 21 CFR 820.75(a)Process validation3
- 21 CFR 820.90(a)Nonconforming product3
Activity by year
2015: 2, 2016: 2, 2017: 1, 2018: 1, 2019: 1, 2021: 1, 2024: 1
Where
Tennessee 7 · California 1 · Florida 1
Often inspects with
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Inspection history
9 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-11-07 | 483 Dexcom, IncNov 7, 2024 · San Diego, California | San Diego, California | 7 | |
| 2021-11-05 | 483 B. Braun US Pharmaceutical Manufacturing LLCNov 5, 2021 · Daytona Beach, Florida | Daytona Beach, Florida | 4 | |
| 2019-05-02 | 483 Advanced Machine, IncMay 2, 2019 · Winchester, Tennessee | Winchester, Tennessee | 2 | |
| 2018-08-22 | 483 Diasol East, Inc.Aug 22, 2018 · Watertown, Tennessee | Watertown, Tennessee | 12 | |
| 2017-03-17 | 483 Diasol East, Inc.Mar 17, 2017 · Watertown, Tennessee | Watertown, Tennessee | 1 | |
| 2016-10-21 | Amended 483 Customer Service Associates, LLCOct 21, 2016 · Winchester, Tennessee | Winchester, Tennessee | 7 | |
| 2016-03-10 | 483 Somnowell, IncMar 10, 2016 · Bellevue, Tennessee | Bellevue, Tennessee | 9 |
About this profile
What does Mary A. Millner inspect?
Mary A. Millner appears on 9 documents on file covering 7 sites, mostly in Tennessee.
What do they cite most often?
21 CFR 820.100 (corrective and preventive action), followed by 21 CFR 820.30(c) and 21 CFR 211.42(b).
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 Mary A. Millner is dated Nov 7, 2024.