FDA Inspection
International Trading Pharm Lab IncInternational Trading Pharm Lab Inc – FDA Inspection, Oct 29, 2019
Record Details
This FDA Inspection record concerns International Trading Pharm Lab Inc, with an inspection on October 29, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 29, 2019
- Product Type
- Drugs
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ID · 3a44a3ca-a18c-4c3d-9135-84140c0e49c8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1107845
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
6- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of International Trading Pharm Lab Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 21, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 16, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 29, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 21, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 23, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for International Trading Pharm Lab Inc
- FDA Inspection 1218305 - 2023-09-21
- FDA Inspection 1153840 - 2021-09-16
- FDA Inspection 972377 - 2016-04-29
- FDA Inspection 832537 - 2013-05-21
- FDA Inspection 782998 - 2012-05-23
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