Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
21 CFR 211.166(a). Results not used for expiration dates, storage cond. Results of stability testing are not used in determining appropriate storage conditions and expiration dates.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
21 CFR 211.22(a). Lack of quality control unit There is no quality control unit.
21 CFR 211.42(c)(1). Incoming material area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of labeling pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging.
21 CFR 211.67(b)(3). Cleaning SOPs/instructions Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
21 CFR 211.25(b). Supervisor Training/Education/Experience Individuals responsible for supervising the manufacture, processing, packing and holding of a drug product lack the education, training and experience to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.
21 CFR 211.125(a). Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.
21 CFR 211.84(d)(1). Component identity verification Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
21 CFR 211.100(b). Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not recorded.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Vista, California, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.