Crystal Monroy
FDA investigator
Appears on 15 documents from 2014 to 2026, most often at sites in California. Most often cites production record review (21 CFR 211.192).
- 15
- Documents on file
- 7.3
- Observations per 483
- 2014
- First seen
- 2026
- Most recent
What they cite most
From 110 observations- 21 CFR 211.192Production record review10
- 21 CFR 211.160General requirements9
- 21 CFR 211.166Stability testing8
- 21 CFR 211.22Responsibilities of quality control unit8
- 21 CFR 211.100Written procedures; deviations7
- 21 CFR 211.165Testing and release for distribution7
Activity by year
2014: 1, 2021: 1, 2022: 5, 2023: 1, 2024: 3, 2025: 3, 2026: 1
Where
California 7 · Canada 2 · Arizona 1 · China 1 · India 1 · Japan 1
Often inspects with
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Inspection history
15 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-02-13 | 483 K.C. Pharmaceuticals, Inc.Feb 13, 2026 · Pomona, California | Pomona, California | 13 | |
| 2025-09-04 | 483 Sparsha Pharma Usa IncSep 4, 2025 · Oceanside, California | Oceanside, California | 10 | |
| 2025-07-04 | 483 NIPPON RIKA CO., LTD.Jul 4, 2025 · ASHIKAGA, Japan | ASHIKAGA, Japan | 7 | |
| 2025-01-27 | 483 OASIS Medical, Inc.Jan 27, 2025 · Glendora, California | Glendora, California | 10 | |
| 2024-08-20 | 483 ABRYL LABORATORIES PRIVATE LIMITEDAug 20, 2024 · SAS NAGAR, India | SAS NAGAR, India | 3 | |
| 2024-06-21 | 483 Brands International CorporationJun 21, 2024 · Newmarket, Canada | Newmarket, Canada | 19 | |
| 2024-03-01 | 483 Amphastar Pharmaceuticals, Inc.Mar 1, 2024 · Rancho Cucamonga, California | Rancho Cucamonga, California | 6 |
About this profile
What does Crystal Monroy inspect?
Crystal Monroy appears on 15 documents on file covering 14 sites, most often in California.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.160 and 21 CFR 211.166.
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 Crystal Monroy is dated Feb 13, 2026.