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FDA establishment 1027735, Ormond Beach, Florida, United States. Part of Playtex Manufacturing's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 5
Official action indicated: 1
Last inspection ended: Jul 10, 2026
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 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.56(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.
Official Action Indicated (OAI)
Apr 19, 2023
Drugs · Drug Quality Assurance
4 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 fully followed.
21 CFR 211.80(a). Written Procedures Not Followed Written procedures are not followed for the receipt and handling of components.
21 CFR 211.192. Written record of investigation incomplete Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
21 CFR 211.68(b). input/output verification Input to and output from the computer and records or data are not checked for accuracy.
Voluntary Action Indicated (VAI)
Nov 3, 2017
Drugs · Drug Quality Assurance
7 cited references
21 CFR 211.80(a). Written Procedures Not Followed Written procedures are not followed for the receipt and handling of components.
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 211.68(a). Calibration/Inspection/Checking not done Routine checking of electronic equipment is not performed according to a written program designed to assure proper performance.
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 211.65(a). Equipment construction - reactive surfaces Equipment surfaces that contact components, in-process materials and drug products are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
21 CFR 211.160(b)(1). Samples (various types) representative, identified properly Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within each shipment of components are not representative.
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.
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
Ormond Beach, Florida, United States. Part of