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FDA establishment 3014773352, Chennai, India. Part of MMC Healthcare Ltd.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
Inspections: 1
Official action indicated: 1
Last inspection ended: Mar 30, 2024
Warning letters: 1
Import refusals since 2024: 5
Import refusals 2014 to 2023: 1, first Jul 21, 2022
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 211.188(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 211.22(a). Lack of quality control unit There is no quality control unit.
21 CFR 211.103. Actual vs. theoretical yields not determined Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of packaging of the drug product.
21 CFR 211.52. Washing and toilet facilities are deficient Washing and toilet facilities lack hot and cold water.
21 CFR 211.192. Quality control unit review of records Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
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 211.160(a). Following/documenting laboratory controls Established laboratory control mechanisms are not documented at the time of performance. Electronic records are used, but they do not meet system access limitation, audit trail and employee accountability/responsibility policy requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
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.
Official Action Indicated (OAI)
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
Chennai, India. Part of