Warning letter

PT. Primo Indo Ikan: warning letter of May 30, 2019

FDA warning letter 581917 · Center for Food Safety and Applied Nutrition

Key facts

Reference number 581917
Company PT. Primo Indo Ikan
Subject Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Issue date May 30, 2019
Posted date Jul 9, 2019
Issuing office Center for Food Safety and Applied Nutrition
Product type Food/Cosmetics
CFR sections cited 117, 123, 123.3, 123.6, 123.3(b), 123.3(c), 123.6(c)(3), 123.6(g), 123.7(b)
Inspection city Denpasar
Inspection start date Jan 21, 2019
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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