US FDA
International Medication Systems Limited
2026-07-14
Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63). Your (b)(4) system was inadequately designed, monitored, and maintained. You use (b)(4) for cleaning drug manufacturing equipment, and the same system feeds your (b)(4) system. During the inspection, we…
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US FDA
Cosmetic Manufacturers Pty Ltd.
2026-02-17
Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63). You have not demonstrated all equipment used to manufacture finished drug products is suitable for its intended use. You qualified the (b)(4) filler machine for the filling of (b)(4) in (b)(4) mL bottles…
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US FDA
Wells Pharma of Houston, LLC
2025-11-25
Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).
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US FDA
ProRx, LLC
2025-03-04
Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).
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US FDA
Multaler et Cie SAS
2024-11-12
Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63). Your firm uses purified water as a component to manufacture your OTC drug product. The (b)(4) water system was not designed and maintained appropriately for its intended use. For example, your non-circulating…
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US FDA
Aqualex Co., Ltd.
2024-06-18
Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63). Your firm uses (b)(4) water as a component to manufacture your OTC drug product. You failed to adequately design your (b)(4) water system to ensure that it was suitable for producing water used in the…
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