FDA Inspection
Mission Hills, S.A. de C.V.Mission Hills, S.A. de C.V. – FDA Inspection, May 25, 2018
Record Details
This FDA Inspection record concerns Mission Hills, S.A. de C.V., with an inspection on May 25, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 44a0c6ba-10a0-4097-b8ce-87a8f6e54635
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1054190
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.101(d)Component addition checked by 2nd person
- 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 211.198(a)Complaint Handling Procedure
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Mission Hills, S.A. de C.V.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 23, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 26, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mission Hills, S.A. de C.V.
- FDA Inspection 935872 - 2015-06-25
- FDA Inspection 899478 - 2014-09-23
- FDA Inspection 766577 - 2012-01-26
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.