Analysis and Case Study Review: FDA Warning Letter To Tismor Health and Wellness

This article provides a breakdown of an interesting US FDA Warning Letter. This Warning Letter is an excellent example of the remediation activities required by the US FDA when inefficiencies are found around access authorization. On 5 December 2019, the US FDA issued a Warning Letter (320-20-10) to the Australian firm Tismor Health and Wellness Pty Limited, following an inspection conducted on May 20 to 24, 2019.

Reference for Investigation of Out of Specification Results in Pharmaceutical Industry

The main objective of selecting this topic because of many pharmaceutical companies receives the 483 observations/ warning letters from the USFDA. The reason of most of 483 observations/warning letters was inadequate investigation of Laboratory Non-Conformances. It includes Out of specification/Out of trend investigation. The inadequate investigation because of unawareness of regulatory guidance requirements while performing the investigation. If any company receives 483 observations/warning letter it will impact on company reputation in the market and also impact on company revenue. So as to avoid this we should know the some basic concept while performing the out of specification/Out of trend investigation.

ANALISIS PENYELESAIAN KREDIT BERMASALAH PADA BANK BNI 46 CABANG POLEWALI MANDAR

Tujuan Penelitian ini adalah untuk mengetahui cara penyelesaian kredit bermasalah di Bank BNI 46 Cabang Polewali Mandar. Metode yang digunakan untuk penelitian ini adalah metode deskriptif yaitu dengan menguraikan data secara sistematis dari fakta-fakta yang didapat kemudian dihubungkan dengan prosedur penyelesaian kredit bermasalah pada Bank BNI 46 Cabang Polewali Mandar. Terjadinya Kredit bermasalah di Bank BNI 46 disebabkan oleh faktor intern yaitu pejabat kredit mudah dipengaruhi atau dipaksa oleh calon nasabah, kurangnya pemahaman terhadap kebutuhan keuangan yang sebenarnya dari calon nasabah dan manfaat kredit yang diberikan seperti kredit modal kerja digunakan untuk komsumtif, kurangnya pengecekan latar belakang calon nasabah dan juga disebabkan oleh faktor ektern yaitu karena merosotnya perekonomian debitur, terjadinya PHK mendadak ditempat kerja debitur, penurunan omset usaha debitur, dan Upaya penyelesaian Kredit bermasalah yang disebabkan oleh Faktor Intern dilakukan dengan peringatan tertulis dalam bentuk Surat Peringatan (SP), mutasi dan penurunan jabatan, serta upaya penyelesaian Kredit bermasalah yang disebabkan oleh faktor ekstern dilakukan dengan mengirim Surat Peringatan SP I sampai SP 3 melakukan penangihan kepada pihak yang ikut serta menandatangani perjanjian kredit dan terakhir melakukan penarikan dan pelelangan agunan. The purpose of this study was to determine what to find out how to solve problem loans at Bank BNI 46 Polewali Mandar Branch. The data analysis method for this research is descriptive method, namely by describing the data systematically from the facts which can then be linked to the procedure for solving problem loans at Bank BNI 46 Polewali Mandar Branch. The occurrence of non-performing loans at Bank BNI 46 is caused by internal factors, namely credit officials who are easily influenced or forced by prospective customers, a lack of understanding of the actual financial needs of the prospective customer and the benefits of loans such as working capital loans used for commercial use, lack of background checks on candidates customers and also caused by external factors, namely due to the decline in the debtor's economy, sudden layoffs at the debtor's workplace, a decrease in the debtor's business onset, and efforts to resolve problem loans caused by Internal Factors are carried out with written warnings in the form of Warning Letters (SP), mutations and decreases position, as well as efforts to resolve non-performing loans caused by external factors are carried out by sending a warning letter from SP I to SP 3 for invoicing the parties participating in signing the credit agreement and finally making a withdrawal and auction of collateral.

PERAN NOTARIS DALAM MENCEGAH KETERLAMBATAN PELAPORAN MERGER PADA REZIM PERSAINGAN USAHA [THE ROLE OF NOTARIES IN PREVENTING DELAYS IN REPORTING MERGERS IN BUSINESS COMPETITION REGIONS]

<em>In accordance with Law Number 5 of 1999 concerning Competition Law, every corporate action that causes monopoly must be notified to the Business Competition Supervisory Commission (KPPU) in less than 30 (thirty) days. However, not all entrepreneurs are aware of this provision. As consequence of the delay, entrepreneurs are potentially subject to wide range of sanctions starting from warning letter, fines, to the worst scenario which is the cancellation of the corporate action. Law Number 40 of 2007 concerning Company Law governs that all corporate action including mergers, acquisition and consolidation should be drawn in form of notarial deed and the Notary has an access to report such action to the Minister of Law and Human Rights if necessary. While the entrepreneurs appear before the Notary to make merger, acquisition or consolidation deed, the Notary may advise the entrepreneurs to notify KPPU if such merger is potentially fulfill certain condition under Law No.5 of 1999. However, Notary must also be aware that his role is limited by his responsibility to keep private information disclosed by the party before him. In connection with those conditions, this research provides elaboration on how Notary should take a role in merger action and his limitation in it.</em><p><strong>BAHASA INDONESIA ABSTRACT: </strong>Undang-Undang Nomor 5 Tahun 1999 tentang Persaingan Usaha mengatur bahwa dalam hal terjadi aksi korporasi yang menyebabkan monopoli, maka pelaku usaha wajib untuk memberikan pemberitahuan atas peristiwa tersebut dalam jangka waktu 30 (tiga puluh) hari kepada Komisi Pengawas Persaingan Usaha (KPPU). Akan tetapi, tidak semua pelaku usaha memahami ketentuan ini. Oleh sebab itu, pada beberapa kasus pelaku usaha dikenai sanksi yang bervariasi, mulai dari surat teguran, denda dalam jumlah besar, hingga pembatalan<em> </em>aksi korporasi tersebut. Sehubungan dengan kondisi ini, Undang-Undang Nomor 40 Tahun 2007 tentang Perseroan Terbatas mengatur bahwa setiap aksi korporasi yang meliputi penggabungan, peleburan dan pengambilalihan akuisisi harus dituangkan persetujuannya oleh para pemegang saham dalam suatu akta notariil dan dilaporkan oleh Notaris kepada Menteri Hukum dan Hak Asasi Manusia apabila diperlukan. Sehubungan dengan pengaturan tersebut, maka setiap kali para pelaku usaha hadir di hadapan Notaris untuk membuat akta<em> </em>atas aksi korporasi, Notaris dapat mengambil peran untuk mencegah terjadinya keterlambatan pemberitahuan tersebut melalui pemberian penyuluhan kepada para penghadap. Akan tetapi, Notaris juga harus tahu bahwa perannya tersebut juga terbatas pada kewajibannya untuk menjaga informasi dari para pihak yang menghadapnya. Berkaitan dengan hal tersebut, penelitian ini mencoba untuk mengelaborasi peran Notaris dalam mencegah keterlambatan pemberitahuan tersebut sejauh mana peran yang dapat diambil Notaris sehubungan dengan hal tersebut.</p>

Penertiban Izin Mendirikan Bangunan (IMB) di Kecamatan Kuta Utara Kabupaten Badung

Prevention of violations of building construction permits is regulated in a regional regulation where each region has its own power which is called an autonomous region which has an institution in charge of controlling building permits handled by the Civil Service Police Unit. This study aims to determine the authority of local governments in regulating building permits and to analyze law enforcement on buildings that do not have a building permit in North Kuta District, Badung Regency. This study was designed using empirical legal research. The results show that the authority of the local government in controlling building permits aims to regulate the legal relationship between citizens and buildings that are objects of control in order to prevent spatial planning that is not in accordance with the rules. Furthermore, every resident in North Kuta District who owns a building or will build a building is required to have a permit in accordance with the regulations issued by the local government. Then, law enforcement for buildings that do not yet have a Building Construction Permit by providing a warning letter 3 times. If the building owner still ignores the Warning Letter, the Civil Service Police Unit will demolish it according to the Decree from the regional head.

Bureaucracy conflicts in border areas: study on conflict between civilian state apparatus and regent in morotai island regency

Regional bureaucratic conflicts are often caused by regional heads' failure to express the concept of regional bureaucratic development and appear to be political, followed by the regional authorities' egocentrism, causing conflicts for the provincial government's technical implementers (in this case, Civilian State Apparatus. This series of matches has drained energy, costs, and energy for Civilian State Apparatus has been highlighted so that the spirit of bureaucratic reform is highlighted not running optimally. The results of the study show that the conflict begins with the regional head's policy regarding a system of rotation/transfer of positions that are not based on employment regulations, the application of immeasurable reward and punishment, the obligation to take credit, buy a house, and buy a vehicle for state civil apparatus with guaranteed Regional Performance Allowances. Following the position (not having a legal basis) Decree of Promotion for state civil apparatus as much as 611 (3 (three periods of promotion) and the imposition of sanctions for the Acting Regional Secretary of Morotai Island Regency in the form of a Warning Letter for not receiving allowances until an unspecified time limit.

ANALISIS PENERAPAN PENAGIHAN PAJAK DENGAN SURAT PAKSA DALAM MENINGKATKAN PENERIMAAN PAJAK STUDI KASUS PADA KANTOR KPP PRATAMA SUKABUMI

This study aims to determine the analysis of the application of tax collection by force letter in increasing tax revenue at the KPP Pratama Sukabumi office. The population and sample used were the tax authorities or tax collection officers and verifier assistants as many as 15 people at the Tax Office (KPP) Sukabumi Pratama. The sampling technique used is saturated sampling. This study uses qualitative research with an associative approach. Based on the results of research that the application of tax collection by forced letter carried out by the Tax Office of Sukabumi KPP was issued if for 21 days after the warning letter was issued and still had not been paid. Forced letters issued and sent to taxpayers as many as 896 and data on achievement of Tax Return of Pratama Sukabumi, tax revenues in 2019 amounting to Rp1,284,529,911,630.00 from the target set of Rp1,437,487,596,000.00 or equal to 89.36% of the achievement target.

Review of Data Integrity in Pharmaceutical Industry

Data integrity has been in the world for a quite some time. In the pharmaceutical industry, it has been playing a major role in ensuring the correctness and truthfulness of the data. The industry has been upgrading the technologies for the production of drugs, storage and distribution. In the past, the man-made workforce has been upgraded to the machine that too Artificial Intelligence machine, computers etc. In such a case integrity of data is utmost priority for ensuring correctness. Machine and the computer are built to reduce the workforce and make the work convenient for workers. It is helpful in reducing the time load of work but to ensure the honesty of the work; data integrity came into effect. A company which runs with the full GMP regulations will get less warning letter during the audit trials, but a company with proper GMP as well as proper implementation of data integrity will percolate into the audit trials successfully. Ensuring data integrity will help the firm to acquire a smaller number of warning letters or form 483. Efficacy; quality and safety of the drug can be easily achieved by data integrity. Data integrity has revolutionized the pharmaceutical industry. Terms such as ALCOA ALCOA+ plays a major role in the integrity of data and been used by various regulatory agencies such as FDA MHRA etc.

Solusi Atas Problematika Perilaku Budgetary Slack Ditinjau Berdasarkan Etika Akuntan Manajemen

This article objective to find solution for the problematic of budgetary slack behavior based on management accountant ethics. This article examines the problem of budgetary slack and then connecting with management accountant ethics and ends with the preventive solution. This research using qualitative approach with descriptive methods. This article finds that if it's related to management accountant ethics, sanctions for violating the principles of integrity, objectivity, confidentiality, and professionalism are by reducing the annual bonus, rotating positions, demoting positions, and the most extreme by dismissing the employee. Prevention efforts can be done by improving the ethical work climate. While, the violation of the competency principle is by giving warning letter with sanctions for reducing the annual bonus and rotating positions in other divisions. Prevention efforts can be done are providing education and training to improve the competence of the accountants. Keywords: Solution; Budgetary Slack; Management Accountant Ethics.

Development Of Student Attendance Record In Akademi Komunitas Negeri Putra Sang Fajar Blitar Using Codeigniter Framework

<strong><em>Attendance record and calculation absent is a key success for the the teaching and learning process in college. The process of recording attendance using manual signatures makes it difficult to record absent data. This data is important to see the level of student discipline in taking lectures and is an early detection to monitor student discipline by giving a warning letter. For this reason, it is necessary to make an application for student attendance recording that can calculation absent and warning letters. This application is based on the web and using PHP programming language, Codeigniter framework and MySQL for database.</em> <em>Testing this application using blackbox testing and user questionnaires. The results of the black box testing prove that the functionality provided by the application is functioning properly according to planning. Testing with a questionnaire was carried out by distributing to all lecturers and academic staff are 15 respondents, the results of the questionnaire which were divided got a score of 90% of the respondents who chose that this application helped the presence process and the recording of the number of student absences</em></strong>