Laboratory Controls

Details

This is the title of the subpart in the United States regulation that gathers the testing requirements together, so individual laboratory failures are cited under this name. Most findings use the standard sentence that scientifically sound and appropriate specifications, standards, sampling plans, and test procedures were not established, followed by the absence of the quality control unit review and approval required by 211.160(a), or by records not made at the time of performance. What is examined is not whether the result passed but on what basis the specification was set and who approved it.

Related sections

Related terms

Real inspection findings

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

1. Specifically, your firm has not established laboratory controls that include appropriate final specifications for testing and release of your products to assure that each batch conforms to appropriate standards of identity and purity during routine production.

   FDA · FDA Warning Letter · 2024-06-18

2. Your firm failed to establish adequate laboratory controls including microbiological testing and…

   FDA · FDA Warning Letter · 2022-12-06

3. Your firm also failed to establish laboratory controls that include scientifically sound and appropriate specifications designed to ensure conformance with appropriate standards of identity, strength, quality, and purity.

   FDA · FDA Warning Letter · 2025-09-16

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