Monica L. Gutierrez
FDA investigator
Appears on 4 documents from 2023 to 2025, mostly at sites in New Jersey. Most often cites design controls (21 CFR 820.30).
- 4
- Documents on file
- 8.3
- Observations per 483
- 2023
- First seen
- 2025
- Most recent
What they cite most
From 33 observations- 21 CFR 820.30Design controls7
- 21 CFR 820.20Management responsibility3
- 21 CFR 820.22Quality audit3
- 21 CFR 820.50Purchasing controls3
- 21 CFR 820.90(a)Nonconforming product3
- 21 CFR 803.17(a)(2)What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?2
Activity by year
2023: 3, 2025: 1
Where
New Jersey 3 · Utah 1
Often inspects with
Is Monica L. Gutierrez coming to your site?
Our team writes custom reports before an inspection: what this investigator cites most, how they write it up, and how your site's history compares, in one brief you can circulate.
Ask about any investigator in Claude or ChatGPT with the AI connector.
Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-12-03 | 483 ASEPTIKITS, LLCDec 3, 2025 · North Salt Lake, Utah | North Salt Lake, Utah | 7 | |
| 2023-11-06 | Amended 483 Biocore9Nov 6, 2023 · Whippany, New Jersey | Whippany, New Jersey | 12 | |
| 2023-06-26 | 483 Turncare, IncJun 26, 2023 · Pompton Plains, New Jersey | Pompton Plains, New Jersey | 9 | |
| 2023-01-18 | 483 Micro Stamping CorpJan 18, 2023 · Somerset, New Jersey | Somerset, New Jersey | 5 |
About this profile
What does Monica L. Gutierrez inspect?
Monica L. Gutierrez appears on 4 documents on file covering 4 sites, mostly in New Jersey.
What do they cite most often?
21 CFR 820.30 (design controls), followed by 21 CFR 820.20 and 21 CFR 820.22.
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 Monica L. Gutierrez is dated Dec 3, 2025.