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The agency sent a warning letter to Acella Pharmaceuticals detailing CGMP violations and failures to oversee contract manufacturers.
FDA sent a warning letter to Acella Pharmaceuticals (Alpharetta, Georgia), dated August 14, 2020, that details violations of current good manufacturing practices (CGMP) and the production of adulterated products. The letter was issued after an inspection of the company’s Alpharetta facility, which was conducted from Dec. 17, 2019 to Jan. 7, 2020.
During the inspection, investigators found that the company had not established laboratory controls and that an active ingredient assay specification developed with the company’s contract manufacturing organization (CMO) was not appropriate and was outside the acceptance criteria of the United States Pharmacopeia monograph.
In the letter, the agency stated, “We acknowledge that you updated the NP Thyroid active ingredient assay specification as committed in your April 17, 2020, letter. This communication also indicated that there were no lots released exceeding 110.0% made with your current active pharmaceutical ingredient (API) supplier and current process. However, FDA inspected your CMO from May 5 to 15, 2020, and found 13 lots within expiry made with your previous API supplier that exceeded 110.0% USP specification during release or stability testing. We acknowledge that your firm subsequently agreed to voluntarily recall these 13 lots. However, these lots should have been identified in your earlier investigation and communication.” FDA is requesting the company review all products to determine if specifications are appropriate and conduct a risk assessment of any products that lack appropriate specifications.
The company also failed to establish an adequate quality control unit, according to the letter, and failed to properly oversee the CMO to ensure dating claims had adequate stability data. During an inspection of the CMO, long-term stability data was not found to support batches manufactured with the new API supplier. “The validation batches manufactured by your CMO using the new API supplier were made in May and June 2019 yet were not placed into a long-term stability study until May 1, 2020,” the letter stated.
FDA is asking the company to provide an action plan with timelines and summaries of testing results, a comprehensive assessment and remediation plan, and a description of improvements to processes and procedures for conduction CMO audits.
“You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act [Federal Food, Drug, and Cosmetic Act] to ensure safety, identity, strength, quality, and purity,” the agency stated in the letter.