Distribution Records. AXXXXX shall maintain distribution records that contain all of the appropriate information as specified in cGMP.
Distribution Records. In order to enable the Company to comply with the requirements of the European Code of Good Manufacturing Practice (Volume IV of the Rules Governing Medical Products in the European Community), the Distributor shall keep Distribution Records for each Batch of the Product sold to the customers. This information shall be made available to the Company in case of Recall Operation or upon request, within two working days, by sending a fax, confirmed by a letter, to: ViraNative AB Viragen (Scotland) LTD. Tvistevagen 48 Pentland Science Park S-907 00 Xxxx Xxxx Xxxx, Peniculk Sweden Xxxxxxxxxx XX000 XXX Xxxxxx Xxxxxxx Tel no: 00-00-000000 Tel no: 00-000-000-0000 Fax no: 00-00-000000 Fax no: 00-000-000-0000
Distribution Records. Xxxxxx shall maintain for the time periods required by applicable Legal Requirements all of its manufacturing and analytical records, shipment and distribution records and validation data relating to Client Product supplied hereunder, all of which shall contain all of the appropriate information as specified in cGMP.
Distribution Records. Xxxxxxxx agrees to provide Company on a monthly basis with the names, contact information and addresses of customers of Reseller to whom Products were distributed in the preceding month.
Distribution Records. BPS shall maintain distribution records that contain all of the appropriate information as specified in, and as necessary to comply with, cGMP. [ * ] Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities NUVELO and Exchange Act of 1934, as amended. 5.7 Customer Complaints and Adverse Events: NUVELO, as required by cGMP, shall maintain all customer complaint and adverse event files. Any such complaints received by BPS shall be forwarded to NUVELO. NUVELO shall be responsible for the review of the complaint or adverse event to determine the need for an investigation or the need to report to the FDA as required by cGMP. NUVELO shall send to BPS all Drug Product performance or manufacturing-related complaints that relate to BPS’ Production which require investigation and shall provide to BPS reasonable samples of all Drug Product which is the subject of such complaints. BPS shall conduct an investigation for each Drug Product performance or manufacturing-related complaint for which BPS receives a sample and shall report findings and follow-up of each investigation to NUVELO. NUVELO shall make these complaint files available to BPS if and to the extent that they are required during an FDA inspection.
Distribution Records. In order to enable the Company to comply with the requirements of the European Code of Good Manufacturing Practice (Volume IV of the Rules Governing Medical Products in the European Community), the Distributor shall keep Distribution Records for each Batch of the Product sold to the customers. This information shall be made available to the Company in case of Recall Operation or upon request, within two working days, by sending a fax, confirmed by a letter, to: BioNative AB Viragen (Scotland) LTD. Tvistevagen 48 Pentland Science Park S-907 36 Umea Bush Loan, Peniculk Xxxxxx Xxxxxxxxxx EH260 PPZ Xxxxxx Xxxxxxx Xxx xx: 00-00-000000 Xxx xx: 00-131-445-6268 Xxx xx: 46-90-193736 Xxx xx: 00-131-445-6269
Distribution Records. Xxxxxx shall maintain distribution records with respect to Client Product supplied hereunder that contain all of the appropriate information as specified in cGMP.
Distribution Records. In order to enable the Company to comply with the requirements of the European Code of Good Manufacturing Practice (Volume IV of the Rules Governing Medical Products in the European Community), the Distributor shall keep Distribution Records for each Batch of the Product sold to the customers. This information shall be made available to the Company in case of Recall Operation, within two working days, by sending a fax, confirmed by a letter, to: ViraNative AB Xxxxxxxxxxx 00 X-000 00 Xxxx Xxxxxx Tel no: 00-00-000000 Fax no: 00-00-000000
Distribution Records. Traceability is not only a requirement of an effective quality system but also the requirement of regulatory bodies around the world. Keeping proper and appropriate distribution records is an important component of ensuring traceability of products in the market. Complaint records An effective complaint handling system is an important part of any quality system. Any complaint received on a medical device should be evaluated and if necessary, thoroughly investigated and analysed, and corrective actions should be taken. The results of the evaluation should lead to a conclusion regarding whether the complaint was valid, the causes of the complaint, and what actions were necessary to prevent further occurrences. Physical Manufacturers, authorised representative and authorised distributors of medical devices are to:- • maintain records of complaint reports and of actions taken in response to these reports, and produce such records for inspection by the Regulatory Authority in the Member State or an enforcement officer as and when required; and • establish and implement documented procedures to conduct effective and timely investigations of reported problems. Adverse events A number of post-marketing risk assessment measures to ensure the continued safe use of medical devices. These measures include reporting from healthcare professionals, mandatory reporting from medical device dealers, and exchange of regulatory information with other medical device regulatory agencies. The mandatory reporting of AEs by medical device dealers is an important part of the post-market surveillance system. The objective of AE reporting and subsequent evaluations is to improve protection of the health and safety of patients, users and others by disseminating information that may reduce the likelihood of, or prevent repetition of AEs, or alleviate consequences of such repetition.
Distribution Records. The Organization shall maintain accurate books and records of all Donated Goods documenting the distribution of Donated Goods and the purpose of such distribution. Your books and records shall include, but are not limited to, accurate records that reflect the total amounts received and distributed (or used) and outline the procedures the Organization uses to determine that the Donated Goods are used solely for the care of the ill, needy, or infants. The Organization shall keep such books and records for at least four (4) years after the end of the year of the receipt of such Donated Goods, or for such longer period as may be required by applicable federal, state, or local tax regulations. Upon reasonable notice, the Organization shall promptly make such records available to Good360 or Good360’s designee for inspection, audit, or copying upon Good360’s request. The Organization shall promptly provide adequate substantiation and records of the Organization’s distribution of Donated Goods to the Internal Revenue Service and/or Good360 upon request. In addition, the Organization shall comply with all of Good360’s reporting and record keeping requirements for the Organization, as set forth in notices from Good360, including requirements related to IRC § 170(e)(3) and IRC regulations § 1.170A‐4A(b)(2) and (3). Such reporting requirements include the provision of certain information in connection with the Organization’s ordering and/or receiving Donated Goods. Good360 and the donor of the Donated Goods to Good360 may rely on the accuracy of information reported by the Organization and the Organization’s records. Non‐Discrimination Policy The Organization shall adhere to a nondiscrimination policy in accordance with applicable state and federal law.
