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21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.25(c). Inadequate number of personnel The number of qualified personnel is inadequate to perform and supervise the manufacture of each drug product.
21 CFR 211.42(c). Defined areas of adequate size for operations The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
21 CFR 211.58. Buildings not maintained in good state of repair Buildings used in the processing, packing and holding of a drug product are not maintained in a good state of repair.
Voluntary Action Indicated (VAI)
Dec 3, 2018
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Feb 7, 2017
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
May 29, 2015
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Voluntary Action Indicated (VAI)
Feb 5, 2013
Drugs · Drug Quality Assurance
2 cited references
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 211.113(a). Procedures for non-sterile drug products Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.
Voluntary Action Indicated (VAI)
Sep 8, 2010
Drugs · Drug Quality Assurance
3 cited references
21 CFR 211.165(e). Test methods The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established.
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 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
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
Rosenberg, Texas, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.