FDA Inspection
GCAM IncGCAM Inc – FDA Inspection, Aug 4, 2010
Record Details
This FDA Inspection record concerns GCAM Inc, with an inspection on August 4, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- GCAM Inc
- Inspection Date
- August 4, 2010
- Product Type
- Biologics
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ID · 431dfb01-8511-481d-ba53-05cc1f0af21b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 677892
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.68(a)Written calibration / inspection records not kept
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Other FDA inspections of GCAM Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 11, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 25, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 22, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for GCAM Inc
- FDA Inspection 1102522 - 2019-09-16
- FDA Inspection 944048 - 2015-09-11
- FDA Inspection 787933 - 2012-06-25
- FDA Inspection 745694 - 2011-09-22
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