Melanie M. Walker
FDA investigator
Appears on 3 documents from 2019 to 2024, most often at sites in Italy. Most often cites responsibilities of quality control unit (21 CFR 211.22).
- 3
- Documents on file
- 7.7
- Observations per 483
- 2019
- First seen
- 2024
- Most recent
What they cite most
From 23 observations- 21 CFR 211.22Responsibilities of quality control unit5
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
Activity by year
2019: 1, 2023: 1, 2024: 1
Where
Italy 1 · North Carolina 1 · South Carolina 1
Often inspects with
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-05-24 | 483 Patheon Manufacturing Services LLCMay 24, 2024 · Greenville, North Carolina | Greenville, North Carolina | 4 | |
| 2023-02-10 | 483 Nephron Sterile Compounding Center LLCFeb 10, 2023 · West Columbia, South Carolina | West Columbia, South Carolina | 15 | |
| 2019-12-10 | 483 TUBILUX PHARMA SPADec 10, 2019 · POMEZIA, Italy | POMEZIA, Italy | 4 |
About this profile
What does Melanie M. Walker inspect?
Melanie M. Walker appears on 3 documents on file covering 3 sites, most often in Italy.
What do they cite most often?
21 CFR 211.22 (responsibilities of quality control unit), followed by 21 CFR 211.113 and 21 CFR 211.42.
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 Melanie M. Walker is dated May 24, 2024.