Warning letter

Hawkeye Jensen Inc [ARCHIVED]: warning letter of Feb 8, 2011

FDA warning letter 138451 · Philadelphia District Office

Key facts

Reference number 138451
Company Hawkeye Jensen Inc [ARCHIVED]
Subject CGMP for Finished Pharmaceuticals/Misbranded/Adulterated
Issue date Feb 8, 2011
Posted date Feb 8, 2011
Issuing office Philadelphia District Office
Product type Drugs
CFR sections cited 201.66(b)(2), 347, 211.22(d), 211.25(c), 211.100(a), 211.165(a), 310.545(a)(18), 347.20(d), 211.67(b), 201.115, 201.10(c)(1)
Inspection city Shartlesville
Inspection ZIP 19554
Inspection start date Aug 4, 2010
Letter on fda.gov web.archive.org

At a glance

  • 10–99 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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