483s Alert Sample Page

Dear Subscriber,

The following 483s have been added to 483sOnline.com in the past week. To access all available 483s, visit us at http://www.fdanews.com/store/product/detail?productId=36408.

JFC Technologies
Issued: 06/08/2011 Region: Central Inspector: Jose M. Cayuela
Observations: Major equipment was found without records of use.

MSD International GMBH (Puerto Rico Branch), LLC
Issued: 03/31/2011 Region: Southeast Inspector: Ramon A. Hernandez
Observations: Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.

Pfizer Consumer Healthcare
Issued: 03/08/2011 Region: Southeast Inspectors: 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.

Kenwick, Inc.
Issued: 07/30/2010 Region: Pacific Inspector: Lakecha Lewis
Observations: Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in the specifications or manufacturing or control procedures.

Electro-Cap International, Inc.
Issued: 04/28/2011 Region: Central Inspector: Brigitte K. Hofmann
Observations: Your firm has introduced or delivered for introduction into interstate commerce a device that has been significantly changed or modified in materials and chemical composition without submitting a premarket notification to FDA, as required by 21 CFR 807.81(a)(3).

Eastern Cranial Affiliates, LLC
Issued: 04/13/2011 Region: Central

Inspector: James W. Leonette

Observations: Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system with sufficient frequency.

Biolab Company
Issued: 03/01/2011 Region: Southeast Inspector: Rafael Gonzalez
Observations: Production processes were not developed, conducted, controlled, and monitored to ensure that a device conforms to its specifications.

3CPM Company, Inc.
Issued: 02/25/2011 Region: Central Inspector: Merideth K. Rose
Observations: Results of validation of the device software were not adequately documented.

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