# FDA WARNING_LETTER - Reese Pharmaceutical Company - November 24, 2010

Source: https://www.keypedia.com/records/warning_letter/reese-pharmaceutical-company/2316d10f-05d7-4ab3-ab33-c330fe56f0e1

> FDA WARNING_LETTER for Reese Pharmaceutical Company on November 24, 2010. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Reese Pharmaceutical Company
- Inspection Date: 2010-11-24
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: This FDA Warning Letter (CIN-11-160272-16) was issued to Reese Pharmaceutical Company following a November 3-24, 2010 inspection, identifying significant Current Good Manufacturing Practice (CGMP) violations for Finished Pharmaceuticals (21 CFR Parts 210 and 211). These violations render drug products adulterated under 21 U.S.C. § 351(a)(2)(B). The firm's December 10, 2010 response was deemed inadequate.

Key violations include:
1.  **Inadequate Investigations (21 CFR § 211.192):** Failure to thoroughly investigate a mislabeling incident where cold decongestant tablets were labeled as cough expectorant (Lot 091612). The firm failed to identify a root cause, provide rationale for the expectorant product not being at risk, and define an "unaccounted" category in reconciliation. Employee training on revised SOPs "A11-Inspection of Finished Product" and "A16-Custom Imprint Tracking Form" was also not addressed.
2.  **Lack of Labeling Control (21 CFR § 211.125(a)):** Issuing various labels weeks in advance and storing them in uncontrolled open boxes, increasing mix-up risk. The firm's proposed tracking form was

## Related Officers

- [Teresa C. Thompson](https://www.keypedia.com/people/teresa-c-thompson/b41b98e5-2a7c-4f19-923b-058a197a8fd4)

Company: https://www.keypedia.com/companies/reese-pharmaceutical-company/05786687-1522-40a1-9da6-063becd66356

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22