Quality Control Unit (QCU)

Details

This is the name under which the United States regulation fixes the authority and responsibility of the quality unit in the text itself. The most common citation in the corpus is that the responsibilities and procedures applicable to the quality control unit were not in writing or were not fully followed (211.22(d)), cited together with cases where the unit had no authority to approve or reject specifications and procedures (211.22(c)) or had no adequate laboratory facilities (211.22(b)). An organisation chart settles nothing, so check in the records who actually approved batch release and whether the authority to reject was ever overridden by the production schedule.

Related sections

Related terms

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

1. Your firm failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and released for use by the quality control unit.

   FDA · FDA Warning Letter · 2023-09-05

2. Your firm’s quality control unit failed to approve or reject all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product (21 CFR 211.22(c)).

   FDA · FDA Warning Letter · 2026-05-12

3. Your firm failed to retest or reexamine components, as appropriate, for identity, strength, quality, and purity and your quality control unit failed to approve or reject components (21 CFR 211.87).

   FDA · FDA Warning Letter · 2021-11-16

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.