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Kilitch Healthcare India Limited MARCS-CMS 672956 —

Delivery Method:
VIA Electronic Mail

Recipient Name
Mr. Paresh Mehta
Recipient Title
Managing Director
Kilitch Healthcare India Limited

902-B, Godrej Coliseum, Behind Everard Nagar
Off. Eastern Express Highway, Nr. Priyadarshani Circle
Sion (E.), Mumbai 400022

Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

Warning Letter 320-24-29

March 28, 2024

Dear Mr. Mehta:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Kilitch Healthcare India Limited, FEI 3011853060, at R - 904 905 T T C Industrial Road,
Navi Mumbai from October 12 to October 20, 2023.

This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

Because your drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, your drug products are also adulterated within the meaning of section 501(a)(2)(A) of the FD&C Act, 21 U.S.C. 351(a)(2)(A).

We reviewed your November 10, 2023 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

During our inspection, our investigators observed specific violations including, but not limited to, the following.

Insanitary Conditions

Your drug products are adulterated under section 501(a)(2)(A) of the FD&C Act because they were prepared, packed, or held under insanitary conditions. FDA investigators observed your facility to be in a state of disrepair, poorly cleaned and maintained as evidenced by:

  • (b)(4) residue on the (b)(4) adjacent to the HEPA filters in the ISO 5 area.
  • Multiple barefoot employees in an ISO 8 area, without required gowning, including gloves, while handling materials being transferred into the ISO 7 manufacturing area.
  • Operators used visibly dirty restricted access barrier system (RABS) (b)(4) for interventions on the filling line.

Your response is not adequate. While you commit to replacing the (b)(4) that surround the HEPA filtration system, your response does not include an evaluation of the residue on the (b)(4) to determine its identity or investigate the source. You also commit to perform re-training of personnel for gowning requirements and implement a procedure for sterilization of RABS (b)(4), however, you do not evaluate the microbiological impact that lack of proper gowning and unclean RABS (b)(4) has on your classified areas, such as ISO 5, ISO 7, and ISO 8. The potential impact to sterile drug products produced under these insanitary conditions is also not addressed.

CGMP Violations

1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

Poor Practices in the Aseptic Processing Areas

In addition to the insanitary conditions described above, during the inspection of your facility, we observed poor practices and behaviors in ISO 5 areas during the manufacturing of sterile drug products. These poor practices included, but are not limited to:

  • Operators performing interventions on the filling line in ISO 5 areas using a cloth to wipe the (b)(4) of the filling (b)(4) and the conveyor.
  • Operators leaning over the filling line, including open and filled eye drop bottles, blocking unidirectional airflow.
  • Operators in the ISO 5 area not wearing goggles and therefore had exposed skin during line set-up and aseptic processing.
  • Operators observed placing bags of components that made contact with the walls in the ISO 7 area into the ISO 5 area without the bags being disinfected.

Your response is inadequate because it does not address the lack of oversight for the operators’ aseptic behaviors and if the initial training received was sufficient. Further, these poor aseptic practices were not investigated to determine the impact to sterile drug products and aseptic processing areas.

Inadequate Media Fill Program

Your media fills failed to accurately simulate commercial operations. Our inspection found the aseptic operations simulated during your media fills were not sufficiently representative of commercial aseptic manufacturing operations. It is your routine practice not to document interventions of the filling line in the manufacturing batch record during production. Because of this, your program lacks reliable data to determine the quantity and duration of interventions to simulate during media fills. In addition, during the inspection there were numerous interventions performed during routine manufacturing that were either not simulated as part of a media fill, or lacking in quantity and duration in the media fills compared to what was observed during production.

Your response is inadequate. While you commit to document routine interventions during manufacturing, you fail to evaluate the interventions used in your media fill program and whether they represent routine production. Your operators performed numerous, manually intensive interventions during aseptic operations. As such, the quantity and duration of process simulation interventions should closely resemble the actual manufacturing process. If a media fill program fails to incorporate contamination risk factors and closely simulate actual drug product exposure, the state of process control and sterility assurance cannot be accurately assessed.

Inadequate Smoke Studies

Smoke studies performed by your firm are not adequate to show unidirectional airflow in the aseptic processing areas. Multiple instances of turbulent airflow in critical areas of the (b)(4) filling line were noted, including above the filling (b)(4). In addition, smoke study videos did not include set-up of the aseptic processing line or interventions of the filling line that simulate actual manufacturing.

In your response you commit to repeat smoke studies with defined set-up and interventions. This is not adequate as you do not provide details such as who is performing and evaluating the smoke studies, how you will determine what interventions are included, and how you will address potential deficiencies.

See FDA’s guidance document Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing at https://www.fda.gov/media/71026/download.

In response to this letter, provide the following:

  • Your plan to ensure appropriate aseptic practices and cleanroom behavior during production. Include steps to ensure routine and effective supervisory oversight for all production batches.

Also describe the frequency of quality unit (QU) oversight (e.g., audit) during aseptic processing and its support operations.

  • A thorough retrospective review and risk assessment that evaluates how poor aseptic technique and cleanroom behavior may have affected the quality and sterility of your drugs.
  • A comprehensive, independent assessment of the design and control of your firm’s manufacturing operations, with a detailed and thorough review of all microbiological hazards.
  • A detailed risk assessment addressing the hazards posed by distributing drug products with potentially objectionable contamination. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.
  • Complete investigations into all batches with potential objectionable microbial contamination or an out-of-specification (OOS) microbiological result (whether or not later invalidated). The investigations should detail your findings regarding the root causes of the contamination.
  • Comprehensive risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including an independent assessment that includes, but is not limited to:

    o All human interactions within the ISO 5 area
    o Equipment placement and suitability, including ergonomics for each human interaction.
    o Air quality in the ISO 5 area, and surrounding room including, but not limited to, air volume, air flow, and microbial/particulate levels
    o Reduction or elimination of aseptic manipulations and connections (e.g., replacing (b)(4) aseptic connections with (b)(4) system)
    o Facility layout
    o Personnel Flows and Material Flows (throughout all rooms used to conduct and support sterile operations)

  • A detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe specific tangible improvements to be made to aseptic processing operation design and control.
  • A plan to implement systemic remediations that address a pattern of recurring contamination events and ensure sustainable control of your aseptic processing operations.

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

Your firm failed to collect the required amount of environmental and personnel monitoring samples required by your procedures to support the manufacture of sterile drug products. During the inspection, a reconciliation of samples that should have been taken during manufacturing activities and those that were actually taken did not match. Interviews with microbiology laboratory staff and management confirmed that it is your routine practice to fabricate results for samples that were never taken or to alter results for samples that would otherwise fail to meet established specifications.

Batch record information for environmental monitoring (EM) is not recorded at the time of completion. For example, a batch record was being filled out in the microbiology laboratory on October 12, 2023, for batch (b)(4) that was manufactured in March 2023, approximately six months prior to the recorded date. Data for the microbiological activity in the filtration/filling area in the batch record was blank on October 12, 2023. This includes the air sample and non-viable particulate counting start and end times, activity done by signatures and dates, and the checked by signatures and dates. When the record was later provided on October 19, 2023, the record was filled out with times, signatures, and dates in March 2023.

During our inspection, investigators observed multiple sample collections in the ISO 5 and ISO 7 areas, and on personnel that resulted in plate readings with numerous colony forming units (CFUs). Your firm stated that prior to the start of the inspection, where you admitted routine fabrication of environmental monitoring results, no single action limit excursion had been documented, however, FDA investigators observed the following during the inspection:

  • 15 action level excursions for ISO 5 area environmental monitoring samples
  • 13 action level excursions for personnel monitoring samples
  • 5 action level excursions for ISO 7 area environmental monitoring samples

Laboratory technicians falsified this data which is critical to maintaining an ongoing state of control in your aseptic processing facility. Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of date after the record’s retention period ends.

Your response states that a new checklist and procedure for oversight will be implemented. This response is not adequate as it does not address the data integrity issues that were identified by FDA. In addition, your response does not include a holistic review of data recording practices at your facility. Further, your corrective action and preventive action (CAPA) of adding a laboratory quality unit (QU) checklist for microbiologist tasks is not adequate to ensure contemporaneous completion of laboratory records.

In response to this letter, provide the following:

A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.

Data Integrity Remediation

Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document

Data Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.

We acknowledge that you are using an independent third-party consultant to audit your operation and assist in meeting FDA requirements. In response to this letter, provide:

  • A comprehensive investigation into the extent of the inaccuracies in data records and reporting. Your investigation should include:

    o A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.
    o Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.
    o An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility’s operations in which you discovered data integrity lapses.
    o A comprehensive retrospective evaluation of the nature of the testing data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all data integrity lapses.

  • A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.
  • A management strategy for your firm that includes the details of your global CAPA plan. Your strategy should include:

    o A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all the data you generate including analytical data, manufacturing records, and all data submitted to FDA.
    o A comprehensive description of the root causes of your data integrity lapses including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for data integrity lapses remain able to influence CGMP-related or drug application data at your firm.
    o Interim measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drugs, such as notifying your customers, recalling product, conducting additional testing, adding lots to your stability programs to assure stability, drug application actions, and enhanced complaint monitoring.
    o Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company’s data.
    o A commitment to have a qualified consultant conduct extensive annual audits, for at least two years, to assist in evaluating CAPA effectiveness after you have executed your data integrity remediation protocol.
    o Inform FDA if you will be hiring a Chief Integrity Officer who is fully empowered to receive anonymous complaints from employees reporting data integrity concerns and with the authority to ensure any potential breach is promptly investigated (by independent quality assurance function, along with expertise from outside entities whenever needed).
    o A status report for any of the above activities already underway or completed.

3. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)).

Environmental Monitoring Deficiencies

Your environmental monitoring (EM) program is deficient. Locations selected for EM in critical areas such as the ISO 5 aseptic processing line, do not have scientific justification to support the chosen locations. For example, standard operating procedure (SOP) KHIL/RB/QC/036 “Swab Testing” describes locations such as “(b)(4)” without providing details to ensure samples are taken from the same location each time. When asked to provide justification for sampling locations, no documentation was provided.

Additionally, the materials used to perform environmental and personnel monitoring are inadequate. The media used does not contain a neutralizing agent and operators were observed spraying (b)(4) near open plates. The plates themselves were observed numerous times to have desiccated media pulling away from the sides of the plates and cracking.

Your response is inadequate as you do not include a risk based, scientific study to determine sampling locations for your environmental monitoring. In addition, you failed to evaluate how the growth media and plate deficiencies potentially impact your drug products and facility’s state of control for microbial contamination.

Facility Maintenance Deficiencies

During the inspection, numerous instances of your facility being in a state of disrepair or unclean were noted. This includes but is not limited to:

  • (b)(4) surrounding the HEPA filters in the ISO 5 area were detached, creating gaps where air from the ISO 7 area could flow into the ISO 5 area.
  • Hose connected to a leaking purified water use point was submerged in a bucket of stagnant water.
  • Peeling paint, stains, and residue on the ceiling of the (b)(4) room.

Your response is inadequate as you failed to consider that persistently deficient environmental controls (e.g., poor design of processing lines, lack of data integrity, and insufficient environmental monitoring) provide a fundamental lack of meaningful retrospective data to support sterility assurance.

A vigilant ongoing EM program, and supporting laboratory, are essential to detect and respond to potential product contamination hazards in your manufacturing environment in a timely manner. Loss of environmental control in an aseptic manufacturing facility can ultimately pose a serious hazard to patients.

In response to this letter, provide:

  • An independent assessment of your EM program including, but not limited to, establishing appropriate limits, sampling frequencies, investigating deviations, and trend analysis. Also ensure the implementation of a comprehensive CAPA plan.
  • Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.

4. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

Your firm’s QU failed to adequately execute its responsibilities. For example:

A. Your QU failed to follow approved, written production and process controls. Your firm was manufacturing Multi Action Relief Drops, Polyvinyl Alcohol 0.5%, Povidone 0.6%, and Tetrahydrozoline HCl 0.05% using non-pharmaceutical grade (b)(4) as a preservative. When your customer requested a switch to pharmaceutical grade (b)(4), you proceeded to repeat process validation without opening a change control per SOP KHIL/RB/QA/016/-R07, “Change Control.” You also failed to conduct a risk assessment of product that was in the U.S. market with non-pharmaceutical grade (b)(4).

B. Your QU released drug product batches of Equate Hydration Polyethylene Glycol 400 and Propylene Glycol Eye Drops (b)(4) before the process validation was completed, as required in your SOP KHIL/RB/QA/081 “Process Validation.” Your QU stated that due to a customer request they released the product for distribution before the studies were completed (21 CFR 100(a)).

C. Your QU failed to ensure that adequate stability data supported your drug expiration dates. Equate Hydration Polyethylene Glycol 400 and Propylene Glycol Eye Drops (b)(4) was released with a (b)(4) expiration date based on only three months of accelerated stability data. (21 CFR 211.166(b)).

D. Your sampling plan to test for diethylene glycol (DEG) and ethylene glycol (EG) in polyethylene glycol is not representative. For example, when receiving the same vendor lot of polyethylene glycol multiple times, only the first shipment of the lot is sampled and tested for DEG and EG. Subsequent shipments with the same vendor lot are not sampled and tested for DEG and EG (21 CFR 211.84).

Your response is inadequate for the following:

A. You failed to review all formulations to ensure that when required, United States Pharmacopeia (USP) grade materials are used to manufacture drug products for the U.S. market and that change controls are opened when required by your procedure.

B. Procedural updates are not sufficient to address the QU disregarding what was written in the previous version of the SOP to release product without completed process validation.

C. A review of expiration dates and the stability data that support them was not included as part of your response.

D. A plan for testing to verify that DEG and EG was at acceptable levels in all lots of raw materials and finished drug products was not included as part of your corrective action plan.

In response to this letter, provide the following:

  • A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:

    o A determination of whether procedures used by your firm are robust and appropriate.
    o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.
    o A complete and final review of each batch and its related information before the QU disposition decision.
    o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.

  • A comprehensive, independent assessment of your change management system. This assessment should include, but not be limited to, your procedure(s) to ensure changes are justified, reviewed, and approved by your quality unit. Your change management program should also include provisions for determining change effectiveness.

The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.

In response to this letter, provide:

  • A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.
  • A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate CAPA that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.
  • A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s certificate of analysis (COA) instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B, and C of the USP monograph.
  • The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.
  • A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.

Ineffective Quality System

Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production and laboratory operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.

Delay in Drug Product Recall

FDA held a teleconference with your firm and your U.S. Agent on October 25, 2023, to discuss our concerns regarding your sterile ophthalmic drug products. During this call, we recommended that you recall all drug products within expiry due to the insanitary conditions at your facility and other egregious violations, as described in this letter.

Due to the potential public health risks associated with the situation at your facility, the Agency released their own announcement on October 27, 2023 (https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-eye-drops-several-major-brands-due-risk-eye). Despite numerous attempts by the Agency to obtain your recall decision, your firm did not initiate a recall until November 15, 2023 (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kilitch-healthcare-india-limited-issues-voluntary-nationwide-recall-various-eye-drops-potential), approximately three weeks after the initial discussion.

Drug Production Suspended

We acknowledge your commitment to suspend production of all drugs for the U.S. market. In response to this letter, clarify whether you intend to resume manufacturing drugs for the U.S. market at this facility in the future.

If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all corrective action and preventive actions (CAPAs).

CGMP Consultant Recommended

Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit1 of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.


The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.

FDA placed your firm on Import Alert 66-40 on October 23, 2023.

Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.

Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Kilitch Healthcare India Limited, T T C Industrial Road, Navi Mumbai into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3011853060 and ATTN: Sarah Rhoades.


Francis Godwin
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research


1 i.e., Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.

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