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FDA establishment 3006744199, Annaram, India. 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: 0
Last inspection ended: Sep 29, 2022
Warning letters: 0
Import refusals since 2024: 16
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 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 211.42(b). Adequate space lacking to prevent mix-ups and contamination The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between drug product containers, closures and drug products and to prevent contamination.
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 211.165(e). Test methods The accuracy, sensitivity, specificity and reproducibility of test methods have not been established.
21 CFR 211.198(b)(2). Complaint Investigation/Follow-Up Findings Complaint records are deficient in that they do not include the findings of the follow-up.
21 CFR 211.80(a). Written Procedures Not Followed Written procedures are not followed for the storage of components.
21 CFR 211.194(a)(4). Complete Test Data Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
21 CFR 211.160(a). Following/documenting laboratory controls Established laboratory control mechanisms are not followed and documented at the time of performance.
Voluntary Action Indicated (VAI)
Import Refusals
16 refused shipment lines since 2024, grouped by product and charges
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. 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 and warning letters
Annaram, India. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.