FDA Inspection
MedisourceRxMedisourceRx – FDA Inspection, Sep 27, 2018
Record Details
This FDA Inspection record concerns MedisourceRx, with an inspection on September 27, 2018, issued by the Los Angeles District Office, covering human drugs.
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ID · edce067b-34b5-461a-893a-58fbf6a61073
Inspection Facts
- Inspection number
- 1067011
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.42(c)(10)(v)Cleaning System
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Other FDA inspections of MedisourceRx
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2025 | OAI | Los Angeles District Office | Drug Quality Assurance |
| November 4, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 22, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for MedisourceRx
- FDA Inspection 1272492 - 2025-06-10
- FDA Inspection 1191700 - 2022-11-04
- FDA Inspection 1131719 - 2020-10-22
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