FDA Inspection
San Antonio Extended Medical Care, IncSan Antonio Extended Medical Care, Inc – FDA Inspection, Sep 24, 2010
Record Details
This FDA Inspection record concerns San Antonio Extended Medical Care, Inc, with an inspection on September 24, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 24, 2010
- Product Type
- Drugs
View Company Profile
ID · 79472a8a-b264-484e-ba33-377d305b7a21
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 681997
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.42(c)Defined areas of adequate size for operations
Full citation text and observation details available on the Dashboard.
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.