Enforcement this week includes only two drug warning letters, one of which was issued to a PET drug manufacturer. Firms that are bedeviled by mold findings in both surface and personnel EM would be well served to read this warning letter and the one issued to a sister site last year.
FDA’s focus on e-cigarette supplies continues to be the subject of a flurry of warning letters.
Also, the Federal Trade Commission and the FDA issued a joint warning letter to Rooted Apothecary LLC in Naples, FL. The warning letter is based on a review of the firm’s website and other social media sites from which FDA concludes the CBD products are unapproved new drugs.
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DRUGS | Jiangsu NHWA Pharmaceutical Co., Ltd
Jiangsu NHWA Pharmaceutical Co., Ltd (China) received a warning letter on September 10, 2019 based on the outcome of an inspection ending April 5, 2019. The firm manufactures a variety of USP APIs, including those that were imported into the US by compounding pharmacies. The firm decided they would not ship any products to the US until the remediations have been completed and verified by the FDA to be effective. The warning letter does not mention imposition of an import alert.
Deficiencies include but are not limited to:
- The firm’s stability protocol and methods are based on the Chinese Pharmacopoeia but did not demonstrate that they are equivalent to those in the USP. Required tests in the USP are not identified in the Chinese Pharmacopoeia. Thus, the products distributed into the US are adulterated. Further, degradation studies were not validated.
- The firm did not adequately investigate when foreign particles are identified during color/clarity testing. The root cause and source of the particles was not identified.
DRUGS | Sofie Co., dba Sofie
Sofie Co., dba Sofie (Sanford, FL) received a warning letter on October 10, 2019 based on the outcome of an inspection ending April 12, 2019. Note the warning letter was not sent to the site, but was sent to the President and CEO in Dulles, VA. The warning letter identifies deficiencies that have been identified at other sites in the company’s network including a warning letter issued on September 24, 2018 after an inspection at a site in Haverhill, MA. The firm manufactures drugs used in positron emission tomography (PET) imaging studies.
FDA states “These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate. Your executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements.”
The single deficiency states that the facilities are not adequate to prevent product contamination that might have an adverse impact on product quality. PET drugs are sterile, intended for parenteral administration. The EM program repeatedly covered micro-organisms including multiple fungal isolates in ISO 5 areas. The firm did not put any additional controls or measures in place. Several causes of the mold were identified including a water leak in the raw material acceptance room but remediation actions were not adequate. Fungal isolates were also isolated from personnel monitoring.
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