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FDA establishment 3005835723, Fort Lauderdale, Florida, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 1
Last inspection ended: Oct 23, 2023
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
21 CFR 211.100(a). Approval and review of procedures Written procedures are not drafted, reviewed and approved by the appropriate organizational units.
21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
21 CFR 211.100(a). Changes to Procedures Not Reviewed, Approved Changes to written procedures are not reviewed and approved by the quality control unit.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that components conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.170(b). Reserve samples identified, representative, stored Reserve drug product samples are not retained and stored under conditions consistent with product labeling.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size and suitably located to facilitate operations for its intended use.
21 CFR 211.84(d)(2). Component identification test Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
21 CFR 211.122(d). Label storage access limited to authorized personnel Access to the storage area for labels and labeling materials is not limited to authorized personnel.
21 CFR 211.52. Washing and toilet facilities are deficient Washing and toilet facilities lack hot and cold water.
Official Action Indicated (OAI)
Mar 16, 2017
Drugs · Unapproved and Misbranded DrugsDrugs · Drug Quality Assurance
5 cited references
21 CFR 211.84(a). Components withheld from use pending release Each lot of is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
21 CFR 211.186(b)(8). Description of containers, labels, et. al. Master production and control records lack a description of the drug product containers, closures and packaging materials, a specimen or copy of each label and all other labeling and the signatures and dates entered by the person or persons responsible for the approval of labeling.
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 211.165(a). Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
21 CFR 211.182. Written records kept in individual logs Written records of major equipment are not included in individual equipment logs.
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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports
Fort Lauderdale, Florida, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.