Mindy M. Chou
FDA investigator · also recorded as Mindy Chou
Appears on 37 documents from 2015 to 2026, mostly at sites in New York. Most often cites control of microbiological contamination (21 CFR 211.113).
- 37
- Documents on file
- 5.7
- Observations per 483
- 2015
- First seen
- 2026
- Most recent
What they cite most
From 214 observations- 21 CFR 211.113Control of microbiological contamination26
- 21 CFR 211.160General requirements20
- 21 CFR 211.192Production record review17
- 21 CFR 211.22Responsibilities of quality control unit15
- 21 CFR 211.42Design and construction features15
- 21 CFR 211.67Equipment cleaning and maintenance15
Activity by year
2015: 3, 2016: 6, 2017: 3, 2018: 2, 2019: 5, 2020: 1, 2021: 8, 2022: 1, 2023: 3, 2024: 2, 2026: 3
Where
New York 23 · Pennsylvania 3 · Maryland 2 · Canada 1 · Connecticut 1 · Florida 1
Often inspects with
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Inspection history
37 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-09-03 | 483 OPS International Inc. dba Olympia PharmaceuticalsSep 3, 2026 · Orlando, Florida | Orlando, Florida | 8 | |
| 2026-05-14 | 483 Fresenius Kabi USA, LLCMay 14, 2026 · Grand Island, New York | Grand Island, New York | 2 | |
| 2026-01-14 | 483 US Specialty Formulations LLCJan 14, 2026 · Allentown, Pennsylvania | Allentown, Pennsylvania | 7 | |
| 2024-05-31 | 483 Diora Kimya Sanayi ve Ticaret LimitedMay 31, 2024 · Gaziantep, Turkey | Gaziantep, Turkey | 17 | |
| 2024-05-02 | 483 United Therapeutics CorporationMay 2, 2024 · Silver Spring, Maryland | Silver Spring, Maryland | 3 | |
| 2023-10-13 | 483 Fresenius Kabi USA, LLCOct 13, 2023 · Grand Island, New York | Grand Island, New York | 2 | |
| 2023-05-26 | 483 Patheon Italia S.p.A. Viale Gian Battista Stucchi 110May 26, 2023 · Monza, Italy | Monza, Italy | 2 |
About this profile
What does Mindy M. Chou inspect?
Mindy M. Chou appears on 37 documents on file covering 32 sites, mostly in New York.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.160 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 Mindy M. Chou is dated Sep 3, 2026.