Warning letter

BBC Group Limited: warning letter of Aug 4, 2021

FDA warning letter 614659 · Center for Drug Evaluation and Research

Key facts

Reference number 614659
Company BBC Group Limited
Subject CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Issue date Aug 4, 2021
Posted date Aug 10, 2021
Issuing office Center for Drug Evaluation and Research
Product type Drugs
CFR sections cited 201.128, 211.34, 211.165, 330, 211.67(a), 211.68(b), 211.160(b)
Inspection city Zhangzhou
Inspection start date Mar 22, 2021
Letter on fda.gov fda.gov

At a glance

  • 1–9 CFR sections cited
  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA warning letters

FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.

Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date:

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