§ 606.140 Laboratory controls

Laboratory control procedures shall include:

(a) The establishment of scientifically sound and appropriate specifications, standards and test procedures to assure that blood and blood components are safe, pure, potent and effective.

(b) Adequate provisions for monitoring the reliability, accuracy, precision and performance of laboratory test procedures and instruments.

(c) Adequate identification and handling of all test samples so that they are accurately related to the specific unit of product being tested, or to its donor, or to the specific recipient, where applicable.

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What FDA inspectors cite under § 606.140

Form FDA 483 observations citing this section, fiscal years 2009–2025 (Biologics).

• Establishment of spec., standards, and test procedures 19
• Provisions to monitor lab test procedures & instruments 17
• Adequate identification and handling of test samples 9

FDA guidance that cites § 606.140

• Labeling of Red Blood Cell Units with Historical Antigen Typing Results: Guidance for Industry 20 Dec 2018
• Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry: Guidance for Industry 28 Dec 2017
• Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion: Final Guidance for Industry 1 Sept 2012
• Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001: Guidance for Industry 13 Feb 2001

Amendment history

Federal Register documents that created or amended this section.

• 40 FR 53532 18 Nov 1975