FDA establishment 3000717606, Orchard Park, New York, United States. Part of The Mentholatum Company's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
21 CFR 211.194(a)(1). Sample identification and other information Laboratory records do not include the quantity of the sample.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review 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 211.180(e). Records reviewed annually Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
21 CFR 211.160(b)(3). Acceptance of drug products Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.
Voluntary Action Indicated (VAI)
Jun 17, 2021
Drugs · Drug Quality Assurance
4 cited references
FDCA 760(c)(1). Timing of AE report submission (non-RX drugs) An adverse event report for a nonprescription drug was not submitted to the Secretary of HHS within 15 business days of receipt of the report.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned and 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 211.165(c). Sampling and testing plans not followed Written procedures for sampling and testing plans are not followed for each drug product.
21 CFR 211.48(a). Plumbing System Defects The plumbing system contains defects that could contribute to the contamination of drug products.
Voluntary Action Indicated (VAI)
Jul 9, 2019
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 211.142. Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not followed.
Voluntary Action Indicated (VAI)
Apr 26, 2017
Drugs · Bioresearch Monitoring
None posted
No Action Indicated (NAI)
May 27, 2016
Drugs · Drug Quality Assurance
4 cited references
FDCA 760(b)(1). Failure of responsible person to report AE (non-RX Drug) Serious adverse event(s) for a non-prescription drug used in the United States has not been reported to the Secretary.
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. Electronic records are used, but they do not meet systems validation, audit trail and open systems control requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
21 CFR 211.165(a). Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in written procedures required by current good manufacturing practice regulations.
Voluntary Action Indicated (VAI)
Dec 6, 2013
Drugs · Bioresearch Monitoring
None posted
No Action Indicated (NAI)
Feb 20, 2013
Drugs · Drug Quality Assurance
2 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 211.198(a). Procedures to be written and followed Procedures describing the handling of all written and oral complaints regarding a drug product are not established and followed.
Voluntary Action Indicated (VAI)
Dec 6, 2010
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 211.100(b). Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not recorded.
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