Rozelle G. Smith
FDA investigator
Appears on 3 documents from 2017 to 2018, mostly at sites in Florida. Most often cites written procedures; deviations (21 CFR 211.100).
- 3
- Documents on file
- 6.0
- Observations per 483
- 2017
- First seen
- 2018
- Most recent
What they cite most
From 18 observations- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.165(a)Testing and release for distribution2
- 21 CFR 211.192Production record review2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 111.415What requirements apply to filling, assembling, packaging, labeling, and related operations?1
- 21 CFR 111.560(a)(2)What requirements apply to the review and investigation of a product complaint?1
Activity by year
2017: 2, 2018: 1
Where
Florida 2 · India 1
Often inspects with
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2018-11-30 | 483 CIPLA LIMITEDNov 30, 2018 · Pune, India | Pune, India | 2 | |
| 2017-05-02 | 483 Pharmatech LLCMay 2, 2017 · Davie, Florida | Davie, Florida | 10 | |
| 2017-03-06 | 483 Chemco CorpMar 6, 2017 · Miami Lakes, Florida | Miami Lakes, Florida | 6 |
About this profile
What does Rozelle G. Smith inspect?
Rozelle G. Smith appears on 3 documents on file covering 3 sites, mostly in Florida.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.165(a) and 21 CFR 211.192.
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 Rozelle G. Smith is dated Nov 30, 2018.