# FDA WARNING_LETTER - Pfizer, Inc. - August 10, 2009

Source: https://www.keypedia.com/records/warning_letter/pfizer-inc/33c1b9a8-e127-4e65-af04-08d15fcc71ba

> FDA WARNING_LETTER for Pfizer, Inc. on August 10, 2009. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Pfizer, Inc.
- Inspection Date: 2009-08-10
- Product Type: Drugs
- Office Name: New York District Office
- Summary: This FDA Warning Letter to Pfizer, Inc. details significant violations observed during a June 29 - August 10, 2009, inspection regarding Postmarketing Adverse Drug Experience (PADE) reporting and Prescription Drug Marketing Act (PDMA) compliance.

**PADE Violations (21 CFR 314.80, 314.81):**
*   **Failure to submit ADE reports:** Numerous serious and unexpected ADEs, including for Dalacin, Camptosar, Lyrica, Lipitor, and Viagra (specifically NAION-related visual events), were not submitted within 15 days. Some Viagra reports were misclassified as non-serious.
*   **Inadequate written procedures:** Procedures for identifying, assessing, and reporting adverse events were insufficient, particularly for fosphenytoin (Purple Glove Syndrome), with inadequate training provided to global pharmacovigilance staff.
*   **Late submission of 15-day Alert Reports:** A significant percentage of serious and unexpected ADE reports (4% in one period, 9% in another) were submitted late, some by hundreds of days. This issue persisted despite a new tracking system and prior FDA 483s.
*   **Late submission for waiver products:** Reports for Provera (30-day waiver) and Bextra (60-day waiver) were also submitted late.
*   **Failure to submit reports from postmarketing

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