Findings
1Process validation
Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). Your firm failed to adequately validate your production and process controls. As such, you do not have assurance that you are capable of consistently manufacturing an OTC drug product with defined quality…
2Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). Your firm manufactures an over-the-counter (OTC) topical drug product, Dry Skin Healing Ointment. You failed to adequately test your incoming components used in the manufacture of your drug products for identity. For example, your firm failed to adequately test each shipment of each lot of incoming components at high-risk of diethylene glycol (DEG)…
3Equipment and facility
Your firm failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.58). Our investigators observed water damage and mold-like substance in the entrance way of the R&D Center Building. Additionally, the ceiling of the (b)(4) -floor warehouse in the R&D Center Building was actively leaking during the inspection, and our investigators observed that you attached plastic sheeting to the ceiling in…
About this record
Extracted automatically from the document US FDA published on 2024-04-16. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
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