Issued: 3/1/11
Region: Southeast
Category: Device 483s
Inspection date range: 2/2/11-3/1/11
Pages: 6
Company: Biolab Company
Ave. Teniente Nelson Martinez
N-59 Alturas de Flamboyan
Bayamon, 00959
PR
Inspector(s): Rafael Gonzalez
Observations: Production processes were not developed, conducted, controlled, and monitored to ensure that a device conforms to its specifications.
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