Omni Lens Pvt. Ltd.

Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in responses to our November 21, 2023 and April 5, 2024, requests for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Omni Lens Pvt. Ltd., FEI 3008449456, at 5 Samruddhi Ground Floor, Navrangpura, Ahmedabad, Gujarat.

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

“Green Glo, NDC 17238-920,” “BioGlo, NDC 17238-900,” and “Vista Gonio Eye Lubricant, NDC 77790-022” are misbranded drugs because they were manufactured in a facility that is not duly registered. The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including, but not limited to, the following:

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 lacked an adequate quality unit (QU) to exercise appropriate procedures and controls to ensure your over-the counter (OTC) drug products are manufactured in compliance with CGMP.

Your firm utilized contract manufacturing organizations (CMOs) to perform manufacturing, processing, and packaging activities on your behalf. You received drug products from these CMOs and declared your firm as the manufacturer on import records. You delegated the QU responsibilities to your CMOs. For example, your agreement with (b)(4) states that you “sub-contract to (b)(4) the responsibility for ensuring that the products comply with all provision of the Regulations and Directive.”

By delegating your QU responsibilities, your firm failed to have adequate oversight and procedures for your CMOs to ensure they operate in compliance with CGMPs. The records and information you provided demonstrate that your firm did not effectively exercise its responsibilities to oversee the quality of your CMO’s manufacturing operations. According to documentation provided by your firm, your CMO lacks an adequately designed aseptic processing room where ophthalmic drop products are manufactured and has not performed the following:

• Dynamic airflow visualization studies for aseptic processing

• (b)(4) effectiveness testing for benzalkonium chloride containing ophthalmic products

See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.

In your response to this letter, provide:

• 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

Also describe how top management supports quality assurance and reliable operations, including but not limited to timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.

Under section 510 of the FD&C Act, 21 U.S.C. 360, and 21 CFR Part 207 of FDA regulations, firms that manufacture, prepare, propagate, compound, or process drugs in the United States or that are offered for import into the United States must be registered with the FDA. Every person who is required to register must, at the time of initial registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution under section 510(j) of the FD&C Act, 21 U.S.C. 360(j).

“Green Glo, NDC 17238-920,” “BioGlo, NDC 17238-900,” and “Vista Gonio Eye Lubricant, NDC 77790-022” are manufactured at (b)(4) and (b)(4), establishments that are not duly registered with FDA. Under section 502(o) of the FD&C Act, a drug is misbranded if it was manufactured in an establishment not duly registered under section 510. Therefore, “Green Glo, NDC 17238-920,” “BioGlo, NDC 17238-900,” and “Vista Gonio Eye Lubricant, NDC 77790-022” are misbranded drugs under section 502(o) of the FD&C Act. The introduction or delivery for introduction of such product into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.

You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.

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.

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 September 27, 2024.

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 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 listing Omni Lens Pvt. Ltd., at 5 Samruddhi Ground Floor, Navrangpura, Ahmedabad, Gujarat, as the manufacturer 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 3008449456 and ATTN: Carrie A. Hughes.