Recently, Anqing public complaints, reflecting the ” Syringe Packaging bag with hair, “the city after hearing the Food and Drug Administration, immediately to the supplier Fang Anqing Pharmaceutical Co., Ltd. issued the order to correct notice requiring the purchase of the company’s acceptance of further strengthening management to ensure quality sales & Equipments . 7 3 am, Zongyang County Port Town with Village officials, a surname in the village health clinic, said doctors complained that he bought in Anqing Pharmaceutical Co., Ltd. Disposable sterile syringes in the absence of the case opened , the packaging bag as much long hair, this situation has occurred several times. He wondered and said: “This product really sterile?” Dr Cheung said: “In order to facilitate visits by local farmers, six years ago, I opened a home health offices, health room, and some drugs used in medical devices are mostly from Anqing Pharmaceutical Co., Ltd. wholesale. Because several times, and the company’s sales staff are also familiar with, so from January 1, 2008, the bilateral agreement, the health room I needed drugs and some medical equipment by the company’s distribution center, surnamed Shen marketers distribution. ” February 1 this year, as Dr. Zhang’s clinic needs, marketing workers Shen had sent from Anqing Roxithromycin tablets, disposable syringes, wound paste and other drugs and medical devices, has been using the normal . “This year on May 20, surnamed Wang, a local health clinic patients to the transfusion, I tore open the sealed disposable sterile syringe packaging bag, discovered inside a long hair.” Dr Cheung said: “At the time I do not care too much about, give patients to use. patients lost about 20 minutes after medicine, suddenly appeared the symptoms of chills, fever, and I were processed in a timely manner, the patient’s condition was stabilized. after I repeatedly thought, Patients did this situation? also came a day before its health clinic for infusion, everything is normal, the next day why there strange? the second drug used in the same volume and the previous, supposedly will not have errors . is not Nazhi disposable syringes in the ‘mischief’? was in torn packaging bag, which have hair, I suspect it will be clean and disinfected syringe without causing a rift. because the bags were torn open , said the matter was not clear, so I did not go to the seller, but then when I use syringes must carefully look at this. ” “5 26 morning, I was ready to use syringes, they found the sealed packaging bag, re-emerged a long hair. This time I put it down intact.” Dr Cheung said: “The I then contact me on the distribution of medicines and medical equipment salesman who named sink, this situation made him reflect. He said ‘This is normal, it does not matter’. Let me Nazhi ‘problem syringe ‘to him, on condition that the value of 22 yuan to lose two packets (100) the same product, I do not agree. ” 7 4 at 11 am, Zongyang Food and Drug Administration that the situation immediately after the organization of law enforcement officers, the magistrate at the first port to the Town with Village Health Office for verification . After investigation, the clinic Dr. Zhang reflected a one-time use of sterile syringes is from Anqing Pharmaceutical Co., Ltd. purchased. Law enforcement personnel on the spot obtained from the purchase of notes, and that support retrieval of the packaging bag with a one-time use of syringes hair. At the same time, it immediately calls to report this case to the Food and Drug Administration of Anqing City. Municipal Food and Drug Administration attaches great importance, in the afternoon, the rapid organization of law enforcement officers conducted a surprise Pharmaceutical Co., Ltd. Anqing investigation. Present, the “problem” syringe of the investigation and evidence collection is still in progress.
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Anqing: sterile syringes bag as much hair – Syringes, Medical Devices – Medical Devices Industry
Wednesday, August 25th, 2010Serious Side Effects Associated with Accutane
Thursday, August 12th, 2010Since 1982, a division of Hoffmann-La Roche, Inc. has manufactured Accutane in the United States. It is used to treat serious forms of cystic acne. Hoffmann-La Roche Inc. is the prescription drug unit of the Roche Group, one of the worlds leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics.
Accutane is a highly effective oral medication used to treat severe recalcitrant nodular acne that has not been helped by other treatments, including antibiotics. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe” by definition means “many” as opposed to “few or several” nodules.
Accutane, and its generics, contain Isotretinoin. People who suffer from the embarrassments associated with acne need to be aware that Accutane carries a significant risk of adverse side effects in certain patients.
Health complications and the legal issues surrounding those caused by Accutane involve the use by pregnant women and associated birth defects and the use by teenagers and associated depression and suicidal behavior. According to the Food and Drug Administration (FDA), women who are pregnant or who might become pregnant and women who are breastfeeding SHOULD NOT take the drug.
Over the past two decades, Accutane has been linked to a large number of dangerous, even life threatening, side effects including:
* Birth Injuries and Birth Defects
* Depression and Suicidal Tendencies
* Psychiatric Diseases
* Central Nervous System Ailments
* Liver Disease
* Inflammatory Bowel Disease
* Hearing and Vision Problems
* Bone and Muscle Damage
* Pancreatic Damage
As with most prescription drugs, the side effects and severity of complications associated with Accutane vary from patient to patient and from case to case. Not every fetus exposed to Accutane has resulted in a deformed child, however, there is an extremely high risk that a deformed infant may result if pregnancy occurs and the woman has/had been taking Accutane even for very short periods. In addition, there is an increased risk of spontaneous abortion, and there have been reports of premature births associated with the use of Accutane. There have also been reported cases of IQs lower than 85 in some infants.
Similarly, not every teenager or young adult who takes Accutane will experience depression or suicidal thoughts. However, the potential for these side effects has caused enough concern, and are serious enough, that the risks must be addressed and taken very seriously.
Steps have been taken to help prevent Accutane’s potentially dangerous and undesirable side effects. Since the introduction of Accutane, education has played a large part in reducing and preventing the drugs’ fetal risks by reinforcing the importance of pregnancy prevention by women using the drug.
Prevention has not stopped at educating patients. Frequent updates and information on potential side effects of the drug are provided to doctors and other health care professionals. This includes notification to doctors that Accutane may cause depression and/or psychosis, as well as suicide, in some cases. This is to help ensure that health care providers make educated and ethical decisions based on the patients’ history and personal needs. Doctors have also been advised to monitor patients very closely for symptoms of depression.
All prescription drugs come with educational material included in the packaging. Accutane’s packaging advises patients to watch for signs of depression, such as feelings of sadness, irritability, fatigue, loss of appetite, trouble concentrating, thoughts of hurting oneself or suicidal thoughts. Unfortunately, many patients who take Accutane due not consider the possible side effects, as their desire for clear skin and their need to regain a positive self-image takes precedence.
Due to the number of potential complications associated with Accutane and the severity of the side effects, the FDA now requires any potential user to sign a consent form. Additionally, pharmacists must give users a detailed warning brochure from the FDA called a Medguide (Medication Guide). Only three drugs in United States history have been required the use of a Medguide: Accutane, Thalidomide and Mifeprex.
Medical Device – Classifications and Guidelines Set in the Product’s Assembly
Sunday, February 7th, 2010A medical device should not be placed for sale in the market unless it passes industry standards. This is generally because they are used to respond to medical necessities of end users. Equipment irregularities may not just be a reason for hazards on the life of the patient. Even medical professionals are not exempted from unhygienic medical machineries. This is why federal guidelines need to be met.
Federal guidelines are standards set for any item in the market. The Food and Drug Administration or FDA oversees the manufacture of medical devices. Find out how FDA categorizes the industrial items and see the standards behind these industrial products’ assembly.
Three classifications for medical devices
The FDA utilizes Class I, Class II and Class III to simply classify medical devices. Class I devices are those with general controls. Class II are those that mix special and general controls in the facets of the medical gadget. Class III are those that need FDA premarket approval.
Class I medical devices include basic gadgets such as bandages, bedpans and gloves. These devices need safety, sanitation and other medical procedures no matter how less the risk they render to the end user. Class II, on the other hand are devices that pose greater risks. Included on the list are x-ray machines, suture materials and surgical needles. Class III are considered the most hazardous of all medical tools and concrete samples include bone implants and pacemakers.
Guidelines for assembly of medical devices
The federal standards are created in assuring that the medical device is sanitized and more efficient. Both consumers and health practitioners will see the relevance in these guidelines. The necessary steps include registration, listing, premarket notification, premarket approval, investigational device exemption, quality system regulation and labeling requirements.
Registration is that stage of the process where the business should register the medical tool. Renewal is made every year. Listing is that step where the business owner – whether an exporter, manufacturer or remanufacturer – must enlist all the facilities with the FDA. Premarket notification is significant before the end products are marketed while premarket approval is required for any Class III medical device.
Investigational device exemption is different from all the rest of the processes since it is needed only for a certain purpose. This is required when clinical testing is the topmost purpose of the product. On the other hand, both quality system regulation and labeling requirements should be met by the manufacturer. Quality system regulation is that process where facilities for packaging, manufacturing, labeling and storing are inspected. Labeling requirements oversee not just the product label but the details explained on the literature of the medical device.
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