FDA News

WARNING LETTER- Stason Pharmaceuticals, Inc.

July 8, 2020 Dear Mr. Fan: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Stason Pharmaceuticals, Inc., FEI 1000160561, at 11 Morgan, Irvine, from October 3 to 25, 2019. This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal …

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Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets

Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible …

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Can an Isolator still be used without a Cleanroom

  The answer is complicated. Under the current USP 797 guidelines, a compounding aseptic isolator may be used as a substitute for a cleanroom if it is certified to meet ISO 5 under dynamic conditions.  Usually, the certifier will conduct particle tests and airflow studies while a technician is compounding and transferring materials. However, the revised version …

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Cleanroom Training and Evaluation

As cleanroom experts, we also provide on-site clean room training. This is the table of contents for our, joint commission evaluated, clean room training manual.   This on-site training can be implemented in several ways. We have done short courses, that largely involves lecture only in as little as one day on-site. Depending on the …

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Cleanrooms and Space Constraints

  In the cleanroom world, the space that you are willing to allocate to your clean operations is what you will have for the next couple of years. Making the right decision is hard, costly and requires a lot of thinking before committing to any solution. What we think is the best starting point is …

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Submit your Last Comments to USP 797 Revisions

  Next Friday, November 30th, The USP 797 closes for public commenting. There is still plenty of time for more comments to be made. All comments should be submitted via the <797> web page, no later than November 30, 2018. A lot of questions and points were made during the open mic session on the USP …

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Complications Related to TPN and How to Prevent Them

  There are many complications related to the administration of TPN. Total parenteral nutrition (TPN), also known as parenteral nutrition (PN) is a form of nutritional support given completely via the bloodstream, intravenously with an IV pump. Catheter-related bloodstream infection (CR-BSI), also known as sepsis are the most common complications that are associated with the administration …

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Mandatory Steps for Effective Cleanroom Design

  Many manufacturing processes need the very stringent environmental conditions that can only be provided by a cleanroom. Because of the complex mechanical systems and high construction, operating, and energy costs that are associated with cleanrooms, it is important to perform the cleanroom design in a methodical way. When designing and building your cleanroom it …

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New Definition for Sterile Compounding

  Making sterile products is the most critical and difficult type of compounding. The whole chapter was open for public comments during September. We managed to get our hands on a non-paper that has been submitted from the USP. The new law Defines “sterile compounding” as compounding drug products for injection, inhalation or administration in …

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VA Publishes their Pharmacy Design Guide

Earlier this year, The Veteran Administration decided to step into the game of assuring pharmacy compliance with the upcoming USP 797 and USP 800 revisions. From the study that we published this summer, we can clearly see that over a third of the facilities are not meeting much needed requirements. A huge portion of these …

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