Naakesh N. Gomanie
FDA investigator
Appears on 3 documents from 2023 to 2024, mostly at sites in New Jersey. Most often cites design controls (21 CFR 820.30).
- 3
- Documents on file
- 7.3
- Observations per 483
- 2023
- First seen
- 2024
- Most recent
What they cite most
From 22 observations- 21 CFR 820.30Design controls6
- 21 CFR 820.75(a)Process validation3
- 21 CFR 820.90(a)Nonconforming product3
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 820.70(e)Production and process controls2
- 21 CFR 803.17(a)(3)What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
Activity by year
2023: 1, 2024: 2
Where
New Jersey 3
Often inspects with
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-07-17 | 483 Phillips Precision, IncJul 17, 2024 · Elmwood Park, New Jersey | Elmwood Park, New Jersey | 8 | |
| 2024-04-11 | 483 American Spraytech, LLCApr 11, 2024 · North Branch, New Jersey | North Branch, New Jersey | 2 | |
| 2023-11-06 | Amended 483 Biocore9Nov 6, 2023 · Whippany, New Jersey | Whippany, New Jersey | 12 |
About this profile
What does Naakesh N. Gomanie inspect?
Naakesh N. Gomanie appears on 3 documents on file covering 3 sites, mostly in New Jersey.
What do they cite most often?
21 CFR 820.30 (design controls), followed by 21 CFR 820.75(a) and 21 CFR 820.90(a).
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 Naakesh N. Gomanie is dated Jul 17, 2024.