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FDA establishment 3009971047, Opa Locka, Florida, United States. Part of World Perfumes's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 3
Official action indicated: 1
Last inspection ended: May 9, 2025
Warning letters: 1
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 211.80(b). Handling and Storage to Prevent Contamination There was a failure to handle and store components at all times in a manner to prevent contamination.
21 CFR 211.56(a). Sanitation--buildings not clean, free of infestation Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
21 CFR 211.80(a). Procedures To Be in Writing Written procedures are lacking which describe in sufficient detail the testing of components.
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.
Official Action Indicated (OAI)
Nov 20, 2018
Drugs · Drug Quality Assurance
3 cited references
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
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 211.110(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.
Voluntary Action Indicated (VAI)
Nov 14, 2014
Drugs · Drug Quality Assurance
7 cited references
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 211.84(d)(2). Reports of Analysis (Components) Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in current good manufacturing practices and written procedures required by current good manufacturing practice regulations.
21 CFR 211.180(e)(1). Review of representative number of batches Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
21 CFR 211.160(b)(4). Written calibration procedures Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific directions, schedules, limits for accuracy and precision, and provisions for remedial action if limits are not met.
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.
Voluntary Action Indicated (VAI)
Warning Letters
Letters naming this establishment; each opens the letter
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
Opa Locka, Florida, United States. Part of