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FDA establishment 3026274805, Miami Lakes, Florida, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 5
Official action indicated: 2
Last inspection ended: Oct 31, 2025
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 2 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 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not documented at the time of performance.
21 CFR 211.105(a). Identification of containers, lines, equipment All major equipment used during the production of a batch of drug product is not properly identified at all times to indicate contents.
Voluntary Action Indicated (VAI)
Aug 20, 2021
Drugs · Drug Quality Assurance
7 cited references
21 CFR 211.194(a)(2). Suitability of testing methods verified The suitability of all testing methods is not verified under actual conditions of use.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
21 CFR 211.166(a)(3). Valid stability test methods The written stability program for drug products does not include reliable, meaningful and specific test methods.
21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in the particular operations they perform as part of their function and written procedures required by current good manufacturing practice regulations.
21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
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.
Official Action Indicated (OAI)
Jun 17, 2019
Drugs · Drug Quality Assurance
11 cited references
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 111.75(a)(1)(i). Component - verify identity, dietary ingredient You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.
21 CFR 111.27(d)(6). Cleaning compounds - adequate, safe Cleaning compounds or sanitizing agents were not adequate for their intended use and safe under their conditions of use.
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 111.365(a). Conditions, controls -protect; microorganisms, contamination You did not perform manufacturing operations under conditions and controls that protect against the potential for contamination.
21 CFR 211.160(b)(3). Acceptance of drug products Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.
21 CFR 117.40(f). Instruments and Controls Your instruments and controls were not accurate and precise.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
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 117.165(b). Sanitation Controls Verif Procedures: Establish Implement You did not establish adequate written sanitation controls verification procedures for environmental monitoring.
21 CFR 111.75(c). Specifications met - verify; finished batch You did not verify that your finished batch of dietary supplement meets product specifications for strength, composition and limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement.
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
Miami Lakes, Florida, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.