Company Name: Alkem Laboratories　 （India）

Defect Description:

Established laboratory control mechanisms are not documented at the time of performance.

Specifically, A. During our inspection of the QC laboratory on 19 March 2018, we observed your QC Analyst entering data electronically into an excel spreadsheet, in the absence of raw data. This same data was also entered into the 9M Stability Study Logbook for (b)(4) Tablets (b)(4)mg, Batch #(b)(4), manufactured April 2017 (2months late).

B. On 23 March 2018, we observed a QC Executive reviewing an OOS/OOT investigation for (b)(4)mg Tablets, Batch#(b)(4) where the stability and scoring study were OOT. The employee had a pen for signing for the review, but no checklist, paper, or workstation for recording errors. In the event of an error the employee reported, they would notify the Section Head and Analyst, but not document it.

C. On 23 March 2018, we observed an Analytical Worksheet for Raw Materials for (b)(4), Batch#(b)(4), did not contain any data for the UV conducted on 13 March 2018. The QC Analyst that conducted this analysis stated he did not document these recordings on the Analytical Worksheet because his data packet was removed by other Analysts without his knowledge.

D. On 22 March 2018, we observed a manufacturing employee entering tablets weights non-contemporaneously during the manufacturing of (b)(4) tablets USP (b)(4)mg, Batch#(b)(4) in the (b)(4) Block building.

Company Name: Alkem Laboratories　 （India）

Defect Description:

Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.

Company Name: Labocont Industrial SRL 20180309

Defect Description:

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21CFR 211.194(a)).

Your firm does not ensure that complete data from assay testing of your finished drug products and active pharmaceutical ingredients(API) are maintained and reviewed by your quality unit. For example, our investigator observed that an analyst failed to document absorbance data generated during assay analysis, and only reported calculated results.

Because you do not document and maintain complete data from your analyses, it is not possible to evaluate whether the method was followed and data is valid, or to substantively investigate sources of deviations and variation in your laboratory. It is essential that all data generated during analysis is maintained and reviewed to determine whether laboratory procedures are followed, and raw materials and drug products conform to established specifications.

Company Name: Alchymars ICM SM Private Limited ( India )

Defect Description:

Failure to properly maintain equipment and to keep complete records of major equipment maintenance.

Our investigator found damaged product-contact surfaces on your multi-product equipment. For example, the man hole gasket of (b)(4)111 was deteriorating and wrapped in peeling tape. A gasket on the (b)(4)102 was also cracked in one area and wrapped in peeling tape.

Your SOP/ENG/39-1, Gasket Management for Equipments and Pipelines which are in Direct Contact with the Product, section 4.18, requires you to replace gaskets in critical areas, including gaskets for (b)(4)111 and (b)(4)102, (b)(4). Your firm was unable to provide gasket replacement records for this equipment during the inspection.

Furthermore, the most recent records of your firm checking the condition of the gaskets for (b)(4)102 were from January 2017, more than (b)(4) before our inspection.

This is a repeat observation from our February 2015 inspection. We also note that you have found deteriorating gaskets to be the root cause for finished API particle complaints.

Your response is inadequate. You stated that the “involved gasket was immediately substituted” but did not evaluate all other gaskets on your manufacturing equipment. You indicated that you will update your procedure to require a supervisor walk-through to assess product contact surfaces, but did not include sufficient detail(e.g. frequency of equipment inspection). You also failed to address the lack of gasket maintenance records.

Company Name: Cosmecca Korea Co., Ltd. ( Korea )

Defect Description:

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards(21 CFR 211.194(a)).

Our investigator documented multiple examples of falsifying laboratory records. Your quality control laboratory employee stated that he fabricated laboratory data for untested finished drug products by manipulating electronic laboratory records. For example, he changed the file names for test results of previously tested drugs so that the file names appeared to reflect the results of other lots of product. Your firm used this falsified laboratory data to determine the strength of your OTC (b)(4) drug products. Your response stated that your quality assurance manager instructed laboratory analysts to manipulate, falsify, or fabricate data.

Company Name: Keshava Organics Pvt. Ltd ( India )

Defect Description:

Failure to maintain complete laboratory control records for test methods.

In several instances, you failed to maintain complete data for API tested and distributed to the U.S. For example, we found test data sheets with missing sample weights for identity testing, batch/lot numbers for reference standards and reagents, equipment identification, and complete thin layer chromatography data for related compounds.

Company Name: Cosmecca Korea Co., Ltd. ( Korea )

Defect Description:

Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

Laboratory equipment used to generate analytical data for release purposes lacked restricted access. For example, analysts shared usernames and passwords, and all users had administrator rights that permitted them to delete or modify files in high-performance liquid chromatography and gas chromatography equipment. You had no mechanism to facilitate traceability of the individuals who changed, adjusted, or modified data generated by computerized systems.

Company Name: Hunan Norchem Pharmaceutical Co., Ltd ( China )

Defect Description:

Failure to maintain complete data derived from all laboratory tests conducted to ensure your API and intermediates comply with established specifications and standards.

Your firm failed to retain and locate the analytical raw data for batches (b)(4) and (b)(4) of (b)(4)base which you shipped to the United States in 2014. In your response, you stated the “analytical data was not backed up.” You also said that you transferred the instrument that generated the data to your (b)(4) branch in 2015 and that the staff there deleted the data. It is essential to retain raw data to ensure the ability to reconstruct cGMP activities and review raw data, as necessary, for deviations and investigations.

Company Name: Alkem Laboratories ( India )

Defect Description:

A Your firm’s QC department deleted two-thousand one hundred one (2,101) files since 1March 2018 on your network. These files names include, but are not limited to: OOS, OOT, Incidents, Method Verification Reports, chromatographs, calculations, and Stability Reports.