FDA Inspection
Berkshire Medical Center, BBBerkshire Medical Center, BB – FDA Inspection, Aug 31, 2010
Record Details
This FDA Inspection record concerns Berkshire Medical Center, BB, with an inspection on August 31, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Berkshire Medical Center, BB
- Inspection Date
- August 31, 2010
- Product Type
- Biologics
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ID · 3faf7103-c9ae-4488-bdea-f91554115ae0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 680326
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.100(b)(21)Donor notification
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Berkshire Medical Center, BB
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2025 | Not classified | New England District Office | |
| April 6, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 25, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 26, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 29, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Berkshire Medical Center, BB
- FDA Inspection 1260964 - 2025-01-31
- FDA Inspection 1049284 - 2018-04-06
- FDA Inspection 972553 - 2016-05-25
- FDA Inspection 820097 - 2013-02-26
- FDA Inspection 732894 - 2011-06-29
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