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FDA Inspection
•Hemcare of Oregon, Inc.•April 26, 2017

Hemcare of Oregon, Inc. – FDA Inspection, Apr 26, 2017

Record Details

This FDA Inspection record concerns Hemcare of Oregon, Inc., with an inspection on April 26, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Hemcare of Oregon, Inc.
Inspection Date
April 26, 2017
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Nancy E. Byerly (FDA Associated Person)
View Company Profile

ID · ed9c1490-eae0-47c0-8c5c-e610a7e1a475

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1012254
FDA center
Human Drugs
Project area
Unapproved and Misbranded Drugs
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 211.46(b)Equipment for Environmental Control
  2. 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
  3. 21 CFR 211.182Personnel dating/signing equipment log
  4. 21 CFR 211.80(b)Handling and Storage to Prevent Contamination

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Hemcare of Oregon, Inc.

3
DateClassificationOfficeProject area
November 3, 2023NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
October 11, 2019NAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
January 7, 2013VAICenter for Drug Evaluation and ResearchUnapproved and Misbranded Drugs
Other documents for Hemcare of Oregon, Inc.
  • FDA Inspection 1223333 - 2023-11-03
  • FDA Inspection 1123523 - 2019-10-11
  • FDA Inspection 814211 - 2013-01-07

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