FDA Inspection
Productos Roche S.A. de C. V.Productos Roche S.A. de C. V. – FDA Inspection, Mar 3, 2017
Record Details
This FDA Inspection record concerns Productos Roche S.A. de C. V., with an inspection on March 3, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Rhoda B. Eniafe (Issuing Officer)
- Sandra A. Boyd (Investigator)
View Company Profile
ID · 591954f8-37c5-46b6-8021-4e54e4d7a07d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006760
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Productos Roche S.A. de C. V.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 29, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 11, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 23, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Productos Roche S.A. de C. V.
- FDA Inspection 915946 - 2015-02-06
- FDA Inspection 841985 - 2013-05-29
- FDA Inspection 750346 - 2011-08-11
- FDA Inspection 625472 - 2009-10-23
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