FDA Inspection
Industria Farmaceutica Andromaco S.A. de C.V.Industria Farmaceutica Andromaco S.A. de C.V. – FDA Inspection, Jun 1, 2012
Record Details
This FDA Inspection record concerns Industria Farmaceutica Andromaco S.A. de C.V., with an inspection on June 1, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 1, 2012
- Product Type
- Drugs
View Company Profile
ID · a905cf86-7c78-42c6-a6e8-5fb972318385
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 786248
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
15- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Showing 10 of 15 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Industria Farmaceutica Andromaco S.A. de C.V.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 1, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 30, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Industria Farmaceutica Andromaco S.A. de C.V.
- FDA Inspection 1078693 - 2019-02-01
- FDA Inspection 1042708 - 2018-02-01
- FDA Inspection 953016 - 2015-10-30
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.