21 CFR 600.14 - Reporting of Biological Product Deviations by Licensed Manufacturers

What it says

A licensed manufacturer who holds, or who had control over, a distributed biological product must report to FDA as soon as possible, and no later than 45 calendar days after acquiring information reasonably suggesting a reportable event, when the event represents a deviation from CGMP, applicable regulations, standards or the license that may affect the safety, purity or potency of a distributed product. Records of the investigation must be kept.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The reporting clock runs from the time the information is acquired, so deviation and investigation systems need to flag potentially reportable events early.
• Not every deviation is reportable, but the decision and its reasoning should be documented.
• Contract sites and distributors can be involved, so responsibilities need to be clear in quality agreements.

What FDA inspectors look for

• Whether a procedure exists for deciding if a deviation is reportable.
• Whether reports were made within the required time.
• Whether investigations and decisions are documented.

Related regulations