Issued: 3/8/11
Region: Southeast
Category: Drug 483s
Inspection date range: 2/16/11-3/8/11
Pages: 8
Company: Pfizer Consumer HealthCare
St Rd. #3 Km 42.1
Guayama, 00784
PR
Inspector(s): Jose E. Melendez, Eva Merced
Observations: Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
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