Warning letter

Specialty Process Labs LLC: warning letter of May 3, 2022

FDA warning letter 624281 · Division of Pharmaceutical Quality Operations IV

Key facts

Reference number 624281
Company Specialty Process Labs LLC
Subject CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Issue date May 3, 2022
Posted date May 17, 2022
Issuing office Division of Pharmaceutical Quality Operations IV
Product type Drugs
Inspection city Phoenix
Inspection ZIP 85027
Inspection start date Nov 8, 2021
Letter on fda.gov fda.gov

At a glance

  • 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:

Browse all FDA warning letters