FDA Inspection
C.P.M. Contract Pharma GmbH & Co. KGC.P.M. Contract Pharma GmbH & Co. KG – FDA Inspection, Jul 5, 2019
Record Details
This FDA Inspection record concerns C.P.M. Contract Pharma GmbH & Co. KG, with an inspection on July 5, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7567170e-969c-49b7-aa41-5720b322bddc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1095436
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of C.P.M. Contract Pharma GmbH & Co. KG
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 7, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 24, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 27, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 5, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for C.P.M. Contract Pharma GmbH & Co. KG
- FDA Inspection 1278839 - 2022-12-08
- FDA Inspection 1009384 - 2017-04-07
- FDA Inspection 934348 - 2015-06-24
- FDA Inspection 852144 - 2013-09-27
- FDA Inspection 740534 - 2011-08-05
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