FDA Inspection
WES Pharma Inc.WES Pharma Inc. – FDA Inspection, Nov 20, 2025
Record Details
This FDA Inspection record concerns WES Pharma Inc., with an inspection on November 20, 2025, issued by the Baltimore District Office, covering human drugs.
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ID · 86fcfabf-984e-4912-bcd9-e4ce9321452c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1290200
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of WES Pharma Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 18, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 28, 2021 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 20, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 19, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for WES Pharma Inc.
- FDA Inspection 1223324 - 2023-11-21
- FDA Inspection 1162565 - 2022-02-18
- FDA Inspection 1141774 - 2021-04-28
- FDA Inspection 1114327 - 2019-12-20
- FDA Inspection 1088267 - 2019-04-19
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