Teresa I. Navas
FDA investigator · also recorded as Oe Thi Eresa Navas, Sens Teresa I. Navas
Appears on 21 documents from 2020 to 2024, mostly at sites in India. Most often cites production record review (21 CFR 211.192).
- 21
- Documents on file
- 5.3
- Observations per 483
- 2020
- First seen
- 2024
- Most recent
What they cite most
From 108 observations- 21 CFR 211.192Production record review12
- 21 CFR 211.160General requirements11
- 21 CFR 211.68Automatic, mechanical, and electronic equipment11
- 21 CFR 211.100Written procedures; deviations10
- 21 CFR 211.113Control of microbiological contamination9
- 21 CFR 211.22Responsibilities of quality control unit8
Activity by year
2020: 1, 2021: 1, 2022: 5, 2023: 8, 2024: 6
Where
India 13 · Japan 6 · Canada 1 · Florida 1
Often inspects with
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Inspection history
21 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-11-22 | 483 Alembic Pharmaceuticals LimitedNov 22, 2024 · Jarod, India | Jarod, India | 5 | |
| 2024-08-02 | 483 Global Calcium Pvt. LimitedAug 2, 2024 · Hosur, India | Hosur, India | 1 | |
| 2024-07-26 | 483 Biocon Biologics LimitedJul 26, 2024 · Bengalurn, India | Bengalurn, India | 10 | |
| 2024-05-31 | 483 AURORE PHARMACEUTICALS PRIVATE LIMITEDMay 31, 2024 · Hyderabad, India | Hyderabad, India | 5 | |
| 2024-04-05 | 483 Eugia Steriles Private LimitedApr 5, 2024 · Anakapalli, India | Anakapalli, India | 3 | |
| 2024-01-19 | 483 Mitsubishi Tanabe Pharma Factory Ltd.Jan 19, 2024 · Onoda, Japan | Onoda, Japan | — | |
| 2023-09-15 | 483 Central Glass CO., LTD.Sep 15, 2023 · UBE, Japan | UBE, Japan | 6 |
About this profile
What does Teresa I. Navas inspect?
Teresa I. Navas appears on 21 documents on file covering 21 sites, mostly in India.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.160 and 21 CFR 211.68.
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 Teresa I. Navas is dated Nov 22, 2024.