WARNING LETTER
Gopaldas Visram & Co., Ltd.
MARCS-CMS 721755 —
June 02, 2026
Delivery Method:
VIA UPS
Reference #:
320-26-86
Product:
Drugs
Over-the-Counter Drugs
Recipient:
Recipient Name
Mr. Mukund V. Thakker
Recipient Title
Director
Gopaldas Visram & Co., Ltd.
Plot No. A /327, TTC Industrial Area, M.I.D.C.,
Mahape
Navi Mumbai
400710
Maharashtra
India
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Warning Letter
320-26-86
June 2, 2026
Dear Mr. Thakker:
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 response to our August 14, 2025 request 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, Gopaldas Visram & Co., Ltd., FEI 3009565091, at Plot No. A /327, TTC Industrial Area, M.I.D.C., Mahape, Navi Mumbai, Maharashtra.
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 of drugs as described in your response to our 704(a)(4) request 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)).
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:
1. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products are manufactured in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity. Your firm also failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.22 and 21 CFR 211.192).
Your firm manufactures multiple OTC
(b)(4)
drug products labeled and formulated to contain active ingredients such as
(b)(4)
. These drug products are also labeled and formulated to contain the inactive ingredient talc. Both talc and asbestos are naturally occurring minerals that may be found in close proximity in the earth. Asbestos is a potential contaminant in talc and is a known human carcinogen when inhaled.
1,2
Additionally, published scientific literature dating back to the 1960s has suggested a possible association between the use of
(b)(4)
containing talc in the
(b)(4)
area and the incidence of
(b)(4)
, potentially linked to asbestos contamination of the talc.
3
The
(b)(4)
you produce can be used on areas of the body which may be an exposure risk (e.g., inhalation or
(b)(4)
area). Your drug products are considered higher-risk drugs as they pertain to patient safety regarding asbestos contamination of talc due to the risk of inadvertent inhalation or potential use in the
(b)(4)
area.
Your quality unit (QU) did not effectively exercise its authority to ensure test procedures and specifications for talc are scientifically sound and appropriate (see 21 CFR 211.160(b)). Furthermore, you did not demonstrate that your firm’s QU has adequate oversight of your contract testing facility. In particular, your QU did not adequately review or approve methods used by your contract laboratory. For example, your QU failed to assure that contract facilities are testing according to your procedures which require you to follow current United States Pharmacopeia (USP) specifications and that results are supported by sufficient information to provide an accurate determination of compliance for identification of talc and absence of asbestos. The infrared (IR) instrument report does not specify the wavenumbers of peak maxima as required in USP for the identification testing conducted. The current USP monograph test for absence of asbestos includes the evaluation of the presence of tremolite chlorite and serpentines through scale expansions of spectra at the required wavenumbers of
(b)(4)
cm-
1
, and in the range of
(b)(4)
cm-
1
to
(b)(4)
cm-
1
. Your instrument report for the spectroscopy was
(b)(4)
cm-
1
to
(b)(4)
cm-
1
and did not include any scale expansions. Your spectra does not evaluate for the presence of serpentines in the range of
(b)(4)
cm-
1
and
(b)(4)
cm-
1
. Additionally, in the identification testing records provided, the IR spectral data shows wavenumber values identical to three decimal places across two independently collected talc samples, which is statistically unlikely and raises concerns regarding the authenticity of the reported results.
Furthermore, our review indicates that your QU failed to investigate data discrepancies associated with identification testing for talc. IR data for talc lot
(b)(4)
identified no maximas, on a scale of approximately
(b)(4)
cm⁻¹ to
(b)(4)
cm⁻¹ scan. The USP identification by IR Absorption has a specification of maxima at
(b)(4)
cm⁻¹,
(b)(4)
cm⁻¹, and
(b)(4)
cm⁻¹. From the scale of the scan, the second peak maxima does not appear to be at a wavenumber greater than
(b)(4)
cm-
1
. Data for your most recent talc lot
(b)(4)
lacks data showing any maxima. The maximas, or lack thereof, in the data you submitted is not consistent with the USP specification for talc.
Your quality system has not adequately ensured 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: Questions and Answers
for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.
Your QU is responsible for fully exercising its authority and responsibilities, including responsibility for approving or rejecting all procedures or specifications impacting the identity, strength, quality, and purity of the drug product. Your firm’s quality systems are inadequate. 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 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, including an evaluation of your contract facility qualification program, to evaluate adherence to appropriate practices.
o Gap analysis for your approved specifications, test methods and laboratory practices for drug components (active and inactive) and those conducted at your contract facility. If notable differences are observed, provide an impact analysis and corrective actions, which may include retrospective testing.
A comprehensive investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data lapses.
A comprehensive review and remediation plan for your Out-of-specification (OOS) result investigation systems. The corrective action and preventive action (CAPA) should include but not be limited to addressing the following:
o QU oversight of laboratory investigations
o Identification of adverse laboratory control trends
o Resolution of causes of laboratory variation
o Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identified
o Adequately scoping of each investigation and its CAPA
o Revised OOS investigation procedures with these and other remediations
2. Your firm approved and released for use one or more lots of components, drug product containers, or closures that did not meet the appropriate written specifications of identity, strength, quality, and purity and related tests under 21 CFR 211.84(d) (21 CFR 211.84(e)).
Your firm released talc component lot
(b)(4)
that did not meet the specification for identity. IR spectral data submitted for talc USP had the wavenumbers of “
(b)(4)
” and “
(b)(4)
”, and the USP specification is maxima at
(b)(4)
cm–
1
,
(b)(4)
cm–
1
, and
(b)(4)
cm–
1
. There was no third wavenumber identification in your records for the sample. The standard used also had only two maximas identified, of “
(b)(4)
” and “
(b)(4)
”. Additional records submitted for talc testing of other lots, do not show any maximas on the spectral instrumentation record.
As a manufacturer, you have a responsibility to sample, test, and examine, as appropriate, drug components before use in production to ensure acceptable specifications for identity, strength, quality, and purity are met. Because you have not performed appropriate testing that detects asbestos in your talc components, among other things, you failed to assure the acceptability of these drug components for use in manufacture of your drug products.
In response to this letter, provide:
Identity, assay and impurity test results from testing retains for all lots of talc containing drug components used in the manufacture of your drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for asbestos. Provide this information within 30 calendar days of the date of this letter.
A description of how you will test each component lot for conformity with all appropriate written specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s Certificates of Analysis (COA) instead of testing each component lot for strength, quality, and purity, specify how you will establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.
A retrospective, independent review of all results for components used for U.S. products for the last three years and a report summarizing the findings of the analysis.
Reformulation to No Longer Use Talc in High-Risk Dosage Forms
In response to our request for records you indicated that you are in the process of reformulating to remove talc as an ingredient and replace with a suitable alternative. In response to this letter provide an update on your reformulation efforts to move to an alternative not associated with risk of talc.
Quality Specifications Regarding Talc
Talc is a USP article, whose specification can be found in the current USP talc monograph. As mentioned above, the specific test for asbestos is included in the talc monograph. Be advised that drugs including components, such as talc, that are recognized in the USP are generally required to meet the current applicable USP monograph under section 501(b) of the FD&C Act. FDA reviewed your specifications for talc components and they are incomplete when compared to the current USP specification. We note that the USP has recently revised its monograph for talc which includes updated technical requirements for asbestos testing in talc and is currently scheduled to be official in
(b)(4)
.
Use of Contract Manufacturers
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.
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
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 refusing admission of articles manufactured at Gopaldas Visram & Co., Ltd., FEI 3009565091, at Plot No. A /327, TTC Industrial Area, M.I.D.C., Mahape, Navi Mumbai, Maharashtra, India 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. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3009565091 and ATTN: Nancy Espinal.
Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
____________________________
1
https://www.cancer.gov/about-cancer/causes-prevention/risk/substances/asbestos
2
https://www.atsdr.cdc.gov/asbestos/health-effects/
3
https://www.fda.gov/cosmetics/cosmetic-ingredients/talc
Content current as of:
06/09/2026
Regulated Product(s)
Drugs
Over-the-Counter Drugs