neroliving.blogg.se - Fda sunscreen recall list

FDA SUNSCREEN RECALL LIST FULL
FDA SUNSCREEN RECALL LIST CODE

You did not ensure that the titanium dioxide, you used as a drug component conforms to United States Pharmacopeia (USP) specifications, as required under section 501(b) of the act. You described your process as simply selecting manufacturers within the United States and speculated these firms may be audited, following regulations, and ensuring raw material quality.Īdditionally, you used food-grade titanium dioxide to manufacture Mr. You could not provide a written procedure for your supplier qualification process.

Identity testing for each component lot used in drug product manufacturing is required, and you may only rely on certificates of analysis (COA) for other component attributes by validating the suppliers’ test results at appropriate intervals.

You failed to adequately test your incoming components for identity before using them to manufacture your drug products. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)). Your firm failed to conduct at least one test to verify the identity of each component of a drug product. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.Ģ. O A summary of all results obtained from testing retain samples from each batch.

FDA SUNSCREEN RECALL LIST FULL

O An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.

A list of chemical and microbial specifications, including test methods, used to analyze each batch of your drug products before a batch disposition decision.

Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.

A comprehensive assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies.

In response to this letter, provide the following: Without adequate testing, you lack basic data to support that each drug product batch conforms to appropriate specifications before release and distribution. Testing is an essential part of ensuring the drug products that you manufacture conform to all predetermined quality attributes, including microbiological specifications and are appropriate for their intended use. Additionally, these testing results are not documented and there are no written procedures for the review and release of finished drug products.ĭrug product batches must be tested for identity, strength, quality, and purity prior to release. You evaluate your drug products for scent, appearance, and texture before you release a batch for distribution. You stated that your firm does not perform assay testing on OTC finished drug products prior to release. market without adequate testing of zinc oxide and titanium dioxide content, the active ingredients in your finished drug products. Your firm released multiple batches of over the counter (OTC) Mr. You failed to perform adequate release testing for each batch of your drug product prior to distribution. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)). Your response is inadequate because it did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP.ĭuring our inspection, our investigators observed specific violations including, but not limited to, the following.ġ. We reviewed your December 13, 2022, response to our Form FDA 483 in detail.

FDA SUNSCREEN RECALL LIST CODE

See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).īecause your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug product is adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. Lulu, LLC, FEI 3021858471, at 815 West 10th Street, Claremont, from November 30 to December 9, 2022. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Mr. Issuing Office: Division of Pharmaceutical Quality Operations IV