Show Details Arthur Mullakandov. Show Details Caryn J Pannone. Ads by Google. We found one company that listed this address in its corporate registration documents — Nature's Prescriptions LLC.
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The top 3 most common problems in the Flushing neighborhood are the following: damaged tree 96 reports , street condition 76 reports , sidewalk condition 48 reports. This address may be also written as nd Strt, NY Ads by BeenVerified More about this property. Possible Owners. County Assessor Records. Any transactions that have been made digitaly accessible by the county this property is located in.
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Show Details. Neighborhood's Major Issues The following pie chart demonstrates the most common issues in ft radius reported to the City via Service Requests, or similar services. Damaged Tree — 96 issues. Search my Location View information about the place where you are now. Salon Aura Inc was registered at this address. Joan Hausmann is associated with this address.
Sh Global Sourcing Inc was registered at this address. United States. May 9, About Warning and Close-Out Letters. Tobacco Retailer Warning Letters. From November 12, to November 22, , a U. During the inspection, the investigator noted that you were not receiving valid prescriptions for individually-identified patients for a portion of the drug products you were producing. In addition, the investigator observed serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk. In addition, your firm failed to demonstrate through appropriate studies that your b 4 is able to provide adequate protection of the area in which products intended or expected to be sterile are processed.
Therefore, your products may be produced in an environment that poses a significant contamination risk.
Nature's Prescriptions - Arteasan
In addition, you do not use sterile disinfectants, including a sporicidal agent, for disinfection of the area. Furthermore, a lack of sterility assurance resulted in a voluntary recall of product on November 13, The CQA otherwise left section A intact, and so clarified that the remainder of section A, including the requirement of valid prescriptions for individually-identified patients, is applicable in every federal judicial circuit.
Accordingly, the drugs you compound without valid prescriptions for individually-identified patients are not entitled to the exemptions in section A. In addition, we remind you that there are a number of other conditions that must be satisfied to qualify for the exemptions in section A of the FDCA.
The drug products that you manufacture and distribute without valid prescriptions for individually-identified patients are misbranded drugs in violation of section f 1 [21 U. In addition, your drug products intended or expected to be sterile are prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health.
As such, all drug products intended or expected to be sterile that you manufacture are adulterated within the meaning of section a 2 A [21 U. Because the drug products for which you have not obtained valid prescriptions for individually-identified patients are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layman can use these drug products safely for their intended uses.
Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section f 1 of the FDCA [21 U.
Additionally, an FDA investigator noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section a 2 A of the FDCA [21 U. Furthermore, you do not use sterile disinfectants, including a sporicidal agent, for disinfection of the area.
An FDA investigator also noted CGMP violations at your facility, causing the drug products for which you have not obtained valid prescriptions for individually-identified patients to be adulterated under section a 2 B of the FDCA [21 U. The violations include, for example:. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes 21 CFR Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions 21 CFR Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas 21 CFR Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates 21 CFR
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