Pharmedica USA, LLC
FDA issued a warning letter to Pharmedica USA, LLC (Phoenix, AZ) following a November 2022 inspection that found the company manufactured preservative-free, multi-dose ophthalmic eye drops and nasal spray products under insanitary conditions without ISO-classified sterile manufacturing areas, no sterility testing, no process validation, and no adequate quality unit. The violations rendered the drug products adulterated under sections 501(a)(2)(A) and 501(a)(2)(B) of the FD&C Act. The company voluntarily ceased all drug manufacturing and distribution, and on March 3, 2023 issued a worldwide recall of Purely Soothing 15% MSM Drops due to non-sterility. FDA warned that failure to address violations could result in seizure, injunction, and withholding of export certificates or new application approvals.
Flagged claims (1)
you were unaware that ophthalmic drug products are required to be sterile, and acknowledged that your facility is not designed and equipped to handle or manufacture sterile drug products, even though your drug products are intended for use as "eye drops."
Required actions (6)
On March 3, 2023, you issued a voluntary worldwide recall of Purely Soothing, 15% MSM Drops (i.e., ophthalmic) due to non-sterility.
On February 14, 2023, you communicated your commitment to cease the manufacturing and distribution of all drug products with no intention of producing drug products in the future and agreed to voluntary recall all drug products manufactured with active ingredient MSM.
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
If you plan to resume any operations regulated under the FD&C Act, notify this office prior to resuming your drug manufacturing operations.
If you resume CGMP activities, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of all CAPA before you pursue resolution of your firm's compliance status with FDA.
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