WARNING LETTER
Laboratorios Dr. Collado S.A.
MARCS-CMS 723285 —
June 02, 2026
Delivery Method:
VIA UPS
Reference #:
320-26-87
Product:
Drugs
Over-the-Counter Drugs
Recipient:
Recipient Name
Mr. José Miranda
Recipient Title
Plant Manager
Laboratorios Dr. Collado S.A.
Parque Industrial Duarte Km 22 ½, Autopista Duarte
Santo Domingo
Dominican Republic
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Warning Letter
320-26-87
June 2, 2026
Dear Mr. Miranda:
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 25, 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, Laboratorios Dr. Collado S.A., FEI 3000989764, at Parque Industrial Duarte Km 22 ½, Autopista Duarte, Santo Domingo Norte, Santo Domingo, as well as subsequent correspondence.
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 failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
Your firm manufactures
(b)(4)
, an OTC
(b)(4)
drug product labeled to contain the active drug ingredient
(b)(4)
. This drug product is 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.
You do not have appropriate written specifications. The current United States Pharmacopeia (USP) talc monograph could be used to meet this requirement for talc; however, your specifications for talc components did not include testing for assay, and multiple impurities (e.g., limits of
(b)(4)
). Notably, you failed to have a specification that includes a test for the absence of asbestos.
Your firm failed to demonstrate that you have appropriate testing procedures and specifications for asbestos testing conducted by your contract testing facility. Your firm uses a contract testing laboratory to test talc for asbestos using Scanning Electron Microscopy (SEM). Analytical SEM data that you submitted, showing magnification levels of only
(b)(4)
, was inadequate to determine the morphology of individual particles in the
(b)(4)
or to reliably detect and characterize potential asbestos fibers.
You have not demonstrated that you appropriately tested incoming talc drug components used in the manufacture of drug products. Additionally, you have not demonstrated that your test methods are validated to show that they are suitable for their intended use. Without adequate testing, you lack scientific evidence that the components conform to appropriate specifications prior to use in the manufacture of your drug products.
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 (drug component) 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, purity, strength, and quality. If you intend to accept any results from your supplier’s 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 revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.
A full risk assessment for drug products that are within expiry which contain any ingredient at risk for asbestos contamination. Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain asbestos. Appropriate actions could include customer notifications and drug product recalls for any contaminated lots.
The chemical quality control specifications you use to evaluate each incoming lot of drug component to determine acceptability for use in manufacturing.
A gap analysis for specifications for drug components (active and inactive) between your current specifications and test procedures against the USP, where applicable. Based on your gap analysis, provide a comprehensive plan for conformance of your drug component specifications and testing to USP standards, where applicable.
A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure (SOP) that describes this COA validation program.
2. 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 (21 CFR 211.22).
Your quality unit (QU) failed to exercise its authority to ensure test procedures and specifications for talc were scientifically sound and appropriate. For example, your firm did not review or approve test methods and specifications for testing asbestos in talc and failed to oversee your contract laboratory ensuring that the facility used a scientifically sound and fit for purpose method. Your QU approved and accepted talc for use in drug manufacturing without ensuring compliance with CGMP.
Your QU is responsible for fully exercising its authority and responsibilities, including responsibility for approving or rejecting all procedures or specifications impacting on 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:
A determination of whether procedures used by your firm are robust and appropriate
Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
A complete and final review of representative batches within expiry and their related information before the QU disposition decision
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.
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)
.
No Longer Manufacture or Distribute Drug Products Containing Talc
In your response to our request for records you indicated that Laboratorios Dr. Collado S.A. will no longer manufacture drug products containing talc as of
(b)(4)
. If you plan to resume production with drug products containing
(talc
, notify this office in writing and include thorough documentation for asbestos testing.
Conclusion
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.
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 refusing admission of articles manufactured at Laboratorios Dr. Collado S.A., Parque Industrial Duarte Km 22 ½, Autopista Duarte, Santo Domingo Norte, Santo Domingo 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 3000989764 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