2019 FDA Warning Letters in the BioPharma Industry So Far

Warning

As 2019 enters its second half, BioSpace takes a look at some of the warning letters issued by the U.S. Food and Drug Administration to the biopharma industry. In March, BioSpace took a look at a number of the warning letters issued across the industry and since then, more companies have been cited for violating regulatory codes.

While many of the warning letters issued by the regulatory agency involve companies that manufacture vaping products or food products, BioSpace takes a look at the ones issued to the biopharma industry.

Rablon – In March, the FDA cited Rablon for selling misbranded and unapproved new drugs, including medications aimed at the abortion market. On its website, Rablon was selling a combination pack of mifepristone and misoprostol tablets, marketed as “Abortion Pill Pack” and was described as a "medicinal treatment that is meant for the [sic] females having urge for discontinuing with their pregnancy.”

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Hospira Healthcare India – The FDA cited Hospira Healthcare India following a 2018 inspection of the company’s manufacturing facility in India. The warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals at the facility. Violations include inadequate record keeping, discrepancies in drug batches, and a lack of quality control in determining if each batch manufactured met CGMP codes.

Laboratorios Quantium LLC – The Florida-based Laboratorios Quantium was also cited for CGMP violations for finished pharmaceutical products. Particularly, the FDA cited concerns over product labeling the showed the product was an unapproved new drug.

Phi Sciences – Arizona-based Phi Sciences was also cited for violations of product labels regarding supplements it sold on its website.

Nutra Pharma – Florida-based Nutra Pharma was cited for selling products on their website that were inappropriately labeled. Following a review, the FDA found that the products sold were classified as unapproved new drugs.

Jubilant Generics – India-based Jubilant was cited for CGMP violations. There were batch discrepancies, as well as concerns over quality control of batches.

Anicare Pharmaceuticals – Also based in India, Anicare was cited for CGMP violations. Concerns included a lack of written testing to assess stability of products, and failures from the quality control team to approve and review written procedures.

King Bio – N.C.-based homeopathic drugmaker King Bio Inc. was cited for selling misbranded drugs, as well as inadequate CGMP procedures. That warning letter followed Kin Bio’s recall of 32 different homeopathic treatments last year. The therapies were recalled due to microbial contamination.

Theodonrx.net – The FDA issued a warning letter to Thedonrx.net for the sale of opioids that are misbranded and unapproved new drugs.

Tec Laboratories – Oregon-based Tec Laboratories was cited for selling a product that “as formulated and labeled,” was an unapproved new drug. The FDA also cited Tec for CGMP violations.

Vanda Pharmaceuticals – Vanda was cited for its websites failure to include any risk information about two drugs, Fanapt and Hetlioz. Fanapt carries a Boxed Warning. The web pages only included the benefits of the medications.

MannKind Corporation – The FDA cited MannKind over a Facebook page promoting its insulin powder, Afrezza. The page made false or misleading claims about the risks associated with Afrezza by suggesting that there are no safety concerns associated with the use of the drug. Afrezza carried a Boxed Warning.

RIJ Pharmaceuticals – The FDA cited RIG over its CGMP violations, including failures to have adequate written procedures and laboratory controls. The company also failed to test its drugs for impurities.

AMMD Labs – Florida-based AMMD Labs was cited by the FDA for significant violations of CGMP regulations for finished pharmaceuticals. The FDA said the company’s methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP.

Centurion Laboratories – India-based Centurion Laboratories was cited for CGMP failures. The facility was faulted for incomplete data regarding testing compliance. The FDA said during its 2018 inspection investigator found torn documents of stability study data, analytical testing sheets, analysis calculations and release forms placed into clear trash bags.

Rocky Mountain Pharmacy – Compounding Rocky Mountain Pharmacy, located in Montana, said the facility failed to live up to compounding safety data established by the FDA. Additionally, the FDA said its investigator noted that drug products were prepared, packed, or held under unsanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health.

Kingston Pharma – New York-based Kingston was cited for CGMP violations. The FDA also noted that over-the-counter children’s medicine was misbranded, which made them ineligible to be sold.

Pharmasol Corporation – The FDA cited two separate Pharmasol Corporation facilities in Massachusetts for CGMP violations. The company failed to investigate batch discrepancies, leaks in the machines and failed to establish an adequate quality control unit.

Ingenue Care – Norwalk, Calif.-based Ingenue was cited for CGMP violations at its manufacturing facility, including the misbranding of drugs produced there.

Vida International – Taiwan-based Vida was cited for CGMP failures at its Taiwan manufacturing facility. The company failed to perform satisfactory batch tests, including the identity and strength of each active ingredient.

McDaniel Life-Line LLC – The FDA cited McDaniel over the sale of products that are unapproved drug formulations. On its website it sells a product called Indian Herb, which the FDA said is classified as unapproved. Also, the FDA said the product was made in a facility that had unsanitary conditions.

Somalabs, Inc. – Somalabs was cited for violating CGMP standards that caused the dietary supplements manufactured on site to be adulterated. The regulatory agency said part of that was due to the company failing to confirm the components in the product met approved standards.

KratomNC – KratomNC was cited for selling unapproved drug products that contain kratom, an herbal extract that has not been approved for use in the U.S., with claims that they could treat or cure opioid addiction and withdrawal symptoms.

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Aurobindo Pharma Limited – Aurobino’s Telangana India facility was cited for significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API). Some of the violations included a failure to ensure that equipment surfaces in contact with API do not alter the quality of the API beyond the official or other established specifications.

Izeen Pharma – Izeen was cited for CGMP violations, including the introduction into interstate commerce of thyroid tablets levothyroxine and liothyronine. The drugs were misbranded and other violations were noted.

Akorn Pharma – The company’s New Jersey site was cited for CGMP violations, including the failure to investigate unexplained discrepancies between batches and failure to exercise controls over computer systems.

Strides Pharma Science Limited – The India-based company was cited for CGMP violations that included the failure to establish an adequate quality control unit and the failure to investigate any unexplained discrepancies in batches.

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