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FDA establishment 1010370, Miami Lakes, Florida, United States. Part of USpharma's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 7
Official action indicated: 0
Last inspection ended: Sep 3, 2026
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 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 211.100(a). Absence of Written Procedures Your firm failed to establish adequate 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 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 803.50(a)(1). Report of Death or Serious Injury An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Voluntary Action Indicated (VAI)
Feb 16, 2023
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Jun 23, 2022
Drugs · Drug Quality Assurance
3 cited references
21 CFR 211.165(e). Test methods The sensitivity of test methods have not been established.
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 211.194(a)(4). Complete Test Data Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
Voluntary Action Indicated (VAI)
Feb 3, 2015
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Apr 2, 2012
Drugs · Postmarket Surv. and EpidemiologyDrugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
May 11, 2010
Drugs · Drug Quality Assurance
2 cited references
21 CFR 211.84(b). Representative Samples Representative samples are not taken of each shipment of each lot of components for testing or examination.
21 CFR 211.84(d)(2). Establish reliability of supplier's C of A Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
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
Miami Lakes, Florida, United States. Part of