FDA Inspection
Recipharm MontsRecipharm Monts – FDA Inspection, Oct 18, 2022
Record Details
This FDA Inspection record concerns Recipharm Monts, with an inspection on October 18, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Recipharm Monts
- Inspection Date
- October 18, 2022
- Product Type
- Drugs
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ID · 1e8094d2-a501-42d5-a694-2a4acf3c64b3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1181620
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(ii)Temperature / Humidity Controls
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of Recipharm Monts
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 29, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 9, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 26, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Recipharm Monts
- FDA Inspection 1116762 - 2019-03-29
- FDA Inspection 940945 - 2015-06-09
- FDA Inspection 821445 - 2013-02-26
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