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FDA Inspection
•Equitech Enterprises, Inc.•October 14, 2011

Equitech Enterprises, Inc. – FDA Inspection, Oct 14, 2011

Record Details

This FDA Inspection record concerns Equitech Enterprises, Inc., with an inspection on October 14, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Equitech Enterprises, Inc.
Inspection Date
October 14, 2011
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 02a2ebe9-baa6-4c54-952f-212913da612a

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
750354
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

5
  1. 21 CFR 600.14(a)(1)Who must report - receiving information
  2. 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
  3. 21 CFR 606.100(b)(14)QC procedures for supplies and reagents
  4. 21 CFR 606.100(b)(10)Controlling storage temperatures
  5. 21 CFR 606.100(b)(3)Preparation of phlebotomy site

Full citation text and observation details available on the Dashboard.

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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