Tekalign Wondimu
FDA investigator
Appears on 12 documents from 2021 to 2026, most often at sites in Virginia. Most often cites insanitary conditions (FDCA 501(a)(2)(A)).
- 12
- Documents on file
- 5.3
- Observations per 483
- 2021
- First seen
- 2026
- Most recent
What they cite most
From 63 observations- FDCA 501(a)(2)(A)Insanitary conditions15
- 21 CFR 211.113Control of microbiological contamination11
- 21 CFR 211.192Production record review8
- 21 CFR 211.67Equipment cleaning and maintenance7
- 21 CFR 211.22Responsibilities of quality control unit5
- 21 CFR 211.84(b)Testing and approval or rejection of components, drug product containers, and closures3
Activity by year
2021: 1, 2022: 2, 2023: 4, 2024: 1, 2025: 2, 2026: 2
Where
Virginia 4 · New York 2 · Canada 1 · Japan 1 · Maryland 1 · New Jersey 1
Often inspects with
Is Tekalign Wondimu 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
12 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-05-12 | 483 Richmond VA Medical CenterMay 12, 2026 · Richmond, Virginia | Richmond, Virginia | 8 | |
| 2026-03-20 | 483 Bora PharmaceuticalsMar 20, 2026 · Baltimore, Maryland | Baltimore, Maryland | 6 | |
| 2025-08-07 | 483 Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-ChoAug 7, 2025 · Suzuka, Japan | Suzuka, Japan | 3 | |
| 2025-05-16 | 483 STAQ Pharma of Ohio, LLCMay 16, 2025 · Columbus, Ohio | Columbus, Ohio | 3 | |
| 2024-09-06 | 483 Annovex Pharma, Inc.Sep 6, 2024 · Lorton, Virginia | Lorton, Virginia | 7 | |
| 2023-10-19 | 483 Vegewax Candleworx LtdOct 19, 2023 · Concord, Canada | Concord, Canada | 5 | |
| 2023-09-19 | 483 Pine Pharmaceuticals, LLCSep 19, 2023 · Tonawanda, New York | Tonawanda, New York | 7 |
About this profile
What does Tekalign Wondimu inspect?
Tekalign Wondimu appears on 12 documents on file covering 12 sites, most often in Virginia.
What do they cite most often?
FDCA 501(a)(2)(A) (insanitary conditions), followed by 21 CFR 211.113 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 Tekalign Wondimu is dated May 12, 2026.