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FDA establishment 3008694072, Winder, Georgia, United States. Part of Winder Laboratories's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 8
Official action indicated: 2
Last inspection ended: Aug 5, 2025
Warning letters: 1
Recalls since 2016: 2
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 211.100(a). Absence of Written Procedures Your firm failed to establish 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 211.166(a). Results not used for expiration dates, storage cond. Results of stability testing are not used in determining expiration dates.
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 211.188(b)(12). Investigations made into any unexplained discrepancy Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed.
21 CFR 211.67(b). Written procedures fail to include Written procedures for cleaning and maintenance fail to include assignment of responsibility, maintenance and cleaning schedules, description in sufficient detail of methods, equipment and materials used, instructions for removal or obliteration of previous batch identification and instructions for protection of clean equipment from contamination prior to use.
21 CFR 211.142. Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not followed.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned, 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 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
21 CFR 211.188(a). Accurate reproduction The batch production and control records are deficient in that they are not an accurate reproduction of the appropriate master production or control record.
21 CFR 211.165(c). Sampling and testing plans not followed Written procedures for sampling and testing plans are not followed for each drug product.
21 CFR 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
21 CFR 211.142(b). Storage under appropriate conditions Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
21 CFR 211.58. Buildings not maintained in good state of repair Buildings used in the manufacturing, processing and holding of a drug product are not maintained in a good state of repair.
Official Action Indicated (OAI)
Feb 5, 2025
Drugs · Bioresearch Monitoring
None posted
No Action Indicated (NAI)
Mar 13, 2020
Drugs · Drug Quality Assurance
4 cited references
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 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
21 CFR 211.84(d)(6). Objectionable microbiological contamination Each lot of a component liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use.
21 CFR 211.198(b)(3). Reason for Not Conducting Complaint Investigation Complaint records are deficient in that they do not document the reason and the individual making the decision not to conduct a complaint investigation.
Voluntary Action Indicated (VAI)
Jul 18, 2018
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Jun 9, 2017
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Feb 25, 2016
Drugs · Drug Quality AssuranceDrugs · Unapproved and Misbranded Drugs
None posted
Voluntary Action Indicated (VAI)
Dec 3, 2015
Drugs · Drug Quality Assurance
10 cited references
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, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations.
21 CFR 211.160(a). Lab controls established, including changes The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
21 CFR 211.89. Quarantine of Rejected Components et. al. Rejected components are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
21 CFR 211.194(a). Complete test data included in records Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
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 211.160(b)(4). Calibration - at intervals, written program, remedial action The calibration of instruments is not done at suitable intervals with provisions for remedial action in the event accuracy and/or precision limits are not met.
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 to facilitate operations for its intended use.
21 CFR 211.25(a). GMP Training Frequency GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
21 CFR 211.142. Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not followed.
21 CFR 211.194(a)(8). Second person sign off Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.
Voluntary Action Indicated (VAI)
Feb 10, 2009
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
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. 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
Winder, Georgia, United States. Part of