Moraima J. Specs
FDA investigator
Appears on 1 document from 2023, mostly at sites in Florida. Most often cites what specifications must you establish? (21 CFR 111.70(b)(1)).
- 1
- Documents on file
- 8.0
- Observations per 483
- 2023
- First seen
- 2023
- Most recent
What they cite most
From 8 observations- 21 CFR 111.70(b)(1)What specifications must you establish?5
- 21 CFR 111.205(a)What is the requirement to establish a master manufacturing record?1
- 21 CFR 111.255(b)What is the requirement to establish a batch production record?1
- 21 CFR 111.27(d)What requirements apply to the equipment and utensils that you use?1
Activity by year
2023: 1
Where
Florida 1
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Inspection history
1 document, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-07-21 | 483 Catalent Pharma Solutions, LLCJul 21, 2023 · St Petersburg, Florida | St Petersburg, Florida | 8 |
About this profile
What does Moraima J. Specs inspect?
Moraima J. Specs appears on 1 document on file covering 1 site, mostly in Florida.
What do they cite most often?
21 CFR 111.70(b)(1) (what specifications must you establish?), followed by 21 CFR 111.205(a) and 21 CFR 111.255(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 Moraima J. Specs is dated Jul 21, 2023.