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FDA establishment 3007517881, Tehsil Baddi, District Solan, India. Part of Macleods Pharmaceuticals's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, its recalls since 2016, and the shipments FDA refused at the border.
Inspections: 6
Official action indicated: 2
Last inspection ended: Oct 20, 2023
Warning letters: 0
Recalls since 2016: 1
Import refusals since 2024: 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 211.68(b). Computer control of master formula records Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
21 CFR 211.166(a)(3). Valid stability test methods The written stability program for drug products does not include reliable, meaningful and specific test methods.
21 CFR 211.110(b). In-process materials specifications In-process specifications are not determined by the application of suitable statistical procedures where appropriate.
21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
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 established, written and followed.
21 CFR 314.81(b)(1)(ii). Contamination, chemical or physical change, deterioration An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
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 conform to appropriate standards of identity, strength, quality and purity.
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.
Voluntary Action Indicated (VAI)
Nov 1, 2021
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Nov 24, 2017
Drugs · Drug Quality Assurance
9 cited references
21 CFR 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
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.
21 CFR 211.84(b). Representative Samples Representative samples are not taken of each shipment of each lot of components for testing or examination.
21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
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.
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 211.170(b). Annual visual exams of drug products Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
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.
Official Action Indicated (OAI)
May 15, 2015
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Feb 22, 2013
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Dec 10, 2010
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Recalls
1 drug, device and biologic recalls since 2016, newest first; 0 Class I
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
Tehsil Baddi, District Solan, India. Part of