FDA Webview

A posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

FSSB Chirurgische Nadeln Gmbh Jestetten, Germany (1/29). Inspected 9/17-9/20/12. The firm failed to establish and maintain procedures to control product that does not conform to specified requirements and that set forth the review and disposition process. The firm has a complaint procedure and a complaint work instruction, but the combination of these documents does not contain the requirement to evaluate complaints to determine if they represent events that should be submitted as a Medical Device Report. It also failed to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, etc. (sterile and non-sterile needles and sutures); FDCA 501(h), 21 CFR 820.90, 820.198(a)(3), 820.70(i), 820.250
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm337808.htm

NX Generation Ltd. Hauppauge, NY (1/25). Inspected 7/18,23,25/12. GMP violations, adulterated: The firm verbally confirmed to an FDA investigator that it does not have written master manufacturing records for the packaging and labeling of approximately (purged) dietary supplements, including children’s chewable and prenatal dietary supplement products that it packages and labels at the facility. The firm also compares the Certificate of Analysis (COA) that accompanies incoming dietary supplements to the COA received with a previous lot of bulk dietary supplements and the firm has not established its own specifications, etc. (dietary supplements); 21 CFR 111.415, 111.70(f), 111.255(b), 111.260, 111.120(b), 111.515
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm337546.htm

Novo Nordisk A/S Bagsvaerd, Denmark (12/12). GMP violations, adulterated: The inspection revealed that about 846 environmental monitoring samples were not collected in the Class 100 (Grade A) and the Class 10,000 (Grade C) areas from 3/2010 to 2/2012 during the manufacture of sterile (purged) products. Operators working inside the aseptic core during the manufacture of (purged) batches were observed wearing goggles that had not been adequately sterilized and had two openings on the top. The Quality Unit failed to investigate and quantify the impurity peak seen at an approximate retention time of (purged) minutes during the high-performance liquid chromatography analysis of certain products, etc. (finished pharmaceuticals); FDCA 501(a)(2)(B), 21 CFR 211.113(b), 211.192
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm337207.htm

Raw Deal, Inc. Flanders, NJ (10/4). Inspected 2/13-3/8/12. GMP violations, adulterated, misbranded: The firm failed to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient prior to its use. It also failed to prepare and follow a written master manufacturing record for its Mens Meal Replacement Blend and Woman Meal Replacement Blend products to ensure uniformity in the finished batch from batch to batch. The firm does not calibrate instruments or controls used in manufacturing or testing a component or dietary supplement to ensure the accuracy and precision of the instruments or controls, etc. (powdered nutritional supplements); 21 CFR 111.75(a)(1)(i), 111.75(c), 111.205(a), 111.255(a), 111.35(b)(2), 111.12(c)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm337648.htm

Sometech Inc. Seoul, Republic of S. Korea (11/26). Inspected 4/23-26/12. CAPAs initiated since the last inspection were reviewed and found deficient in that all required information for the CAPA investigations was not included. Complaints and reportable device malfunctions documented in service reports were received since the last inspection, but were not considered complaints; were not processed through the firm’s complaint handling process; did not include any documentation ensuring the complaints were evaluated to determine whether they represent an MDR reportable event; and did not include the dates the complaints were received, any device identifications and control numbers used; the names, addresses, and phone numbers of the complainants; the dates of the investigations, and any replies to the complainants, etc. (medical imaging equipment and high-frequency surgical instruments); FDCA 501(h), 21 CFR 820.100(a), 820.198(a), 820.30(i), 820.80(c), 820.22, 820.184, 820.25(b), 820.40
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm337815.htm

Tecval Medical Sarl Yverdon-Les-Bains, Switzerland (1/25). Inspected 11/5-7/12. GMP violations, adulterated: The firm has no written procedures for design changes and the form used to document design changes does not address design validation or design verification of design changes. It also failed to establish and maintain procedures for acceptance activities, including inspections, tests, or other verification activities. It has no procedures to control product that does not conform to specified requirements and currently uses a form to document nonconformances, etc. (Flutter Aptalis); FDCA 501(h), 21 CFR 820.30(i), 820.50, 820.80(a), 820.100(a), 820.90(a), 820.198(a), 820.181, 820.22
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm337557.htm