WARNING LETTER
Skin Sciences Laboratory, Inc. MARCS-CMS 524185 —
- Recipient:
- Skin Sciences Laboratory, Inc.
United States
- Issuing Office:
- Center for Drug Evaluation and Research
United States
| |
10903 New Hampshire Avenue Silver Spring, MD 20993 |
Via UPS Warning Letter 320-17-42
July 28, 2017
Mr. Juan Pablo Bertotto
Chief Operating Officer
Skin Sciences Laboratory, Inc.
Unit 101 Central Business Park, Amang Rodriguez Avenue, Manggahan
Pasig City, 1611 Philippines
Dear Mr. Bertotto:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Skin Sciences Laboratory Inc. at Unit 101 Central Business Park, Amang Rodriguez Avenue, Manggahan Pasig City, from January 30 to February 1, 2017.
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 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).
The inspection also revealed that your firm manufactures and distributes unapproved new drugs in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Additionally, FDA has determined that one of the drug products you manufacture is misbranded in violation of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).
We reviewed your February 16, 2017, response in detail and acknowledge receipt of your subsequent correspondence.
During our inspection, our investigator observed specific violations including, but not limited to, the following.
CGMP Violations
1. Your firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
Your firm failed to test your (b)(4) products for identity and strength of active ingredients prior to release and distribution. We note that one of your (b)(4) drug products is labeled for application to (b)(4).
In your response, you stated that you would create a standard operating procedure which requires chemical analysis of active ingredients in your finished drug products prior to release. Your response is inadequate because you did not test your retain samples for all lots of drug product that you have distributed to the U.S. market without appropriate data to support their release.
In response to this letter provide a detailed risk assessment for all drug products within expiry in the U.S. market and test all drug product retain samples for identity and strength of active ingredients.
2. Your firm failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and released for use by the quality control unit (21 CFR 211.84(a)).
Your firm failed to analyze glycerin raw material from your supplier to detect diethylene glycol (DEG) prior to the quality unit releasing the glycerin for use in drug product manufacturing. Glycerin is an ingredient in multiple drug products you manufacture, including Essence Skin Saving Toothpaste, an over-the-counter (OTC) drug product intended for oral use. DEG contamination has resulted in various lethal poisoning incidents in humans worldwide.
In your response, you state you will implement testing to detect DEG in glycerin raw material lots. You also committed to testing any remaining glycerin stock material in your warehouse for DEG. Your response is inadequate because you did not test all lots of drug product that you distributed to the United States for DEG.
In response to this letter provide a detailed risk assessment for drug products that contain glycerin and are within expiry in the U.S. market. Also test retain samples of all lots for DEG.
See FDA’s guidance document, Testing of Glycerin for Diethylene Glycol, to help you meet the CGMP requirements when manufacturing drugs containing glycerin, at https://www.fda.gov/downloads/Drugs/.../Guidances/ucm070347.pdf.
Unapproved New Drug and Misbranding Violations
ESSENCE SKIN-SAVING ANTIPERSPIRANT
Examples of claims observed on your product label for ESSENCE SKIN-SAVING ANTIPERSPIRANT and your website at www.vmvhypoallergenics.com that establish the intended uses of the product include, but may not be limited to, the following:
- “Aggressively inhibits perspiration – strong enough for hyperhidrotic skin (can be used on palms and soles of the feet, too!)
- “Can also be used on palms, soles of feet + other sweaty areas.”
Based on the above claims, ESSENCE SKIN-SAVING ANTIPERSPIRANT is a drug as defined by section 201(g)(1)(B) of the FD&C Act [21 U.S.C. 321(g)(1)(B)], because it is intended to affect the structure or any function of the body. Specifically, this product is intended as an antiperspirant.
Over-the-counter drug products intended as antiperspirants, such as ESSENCE SKIN-SAVING ANTIPERSPIRANT, are subject to the final monograph for antiperspirants, Antiperspirant Drug Products for Over-the-Counter Human Use (21 CFR Part 350). However, this product is not labeled in accordance with this monograph for the reasons explained below.
ESSENCE SKIN-SAVING ANTIPERSPIRANT is intended for use as an antiperspirant for the palms, soles of feet, and other sweaty areas. However, the indications and directions described in the antiperspirant final monograph are limited to the underarms only. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled is generally recognized as safe and effective and therefore, your product is a new drug under section 201(p) of the FD&C Act [21 U.S.C. 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, ESSENCE SKIN-SAVING ANTIPERSPIRANT is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. 352(f)(1)] because the product label does not include adequate directions for use as required under 21 CFR 350.50(d) which requires the statement “apply to underarms only” under the heading “Directions.” Instead, the direction section for ESSENCE SKIN-SAVING ANTIPERSPIRANT contains information such as “can also be used on palms, soles of feet and other sweaty areas” and “excessive sweaty skin, apply before bedtime and reapply in the morning” that go beyond the directions described in the final monograph. Therefore, ESSENCE SKIN-SAVING ANTIPERSPIRANT is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the FD&C Act [21 U.S.C. 331(a)].
VMV HYPOALLERGENICS ESSENCE SIMPLE-GENTLE SKIN-SAVING TOOTHPASTE
Examples of claims observed on your product label for VMV HYPOALLERGENICS ESSENCE SIMPLE-GENTLE SKIN-SAVING TOOTHPASTE that establish the intended uses of the product include, but may not be limited to, the following:
- “[H]elps prevent peri-oral dermatitis (acne + irritations around the mouth + chin) + halogen acne; cleans + fortifies sensitive teeth.”
- “[C]are for skin prone to peri-oral dermatitis (acne / other skin problems around the mouth / chin).”
- “Calcium lactate + xylitol inhibit tarter production and fight cavities.”
- “With coconut-derived monolaurin for antibacterial benefits”
Based on the above claims, VMV HYPOALLERGENICS ESSENCE SIMPLE-GENTLE SKIN-SAVING TOOTHPASTE is a drug as defined by section 201(g)(1)(B) of the FD&C Act [21 U.S.C. 321(g)(1)(B)], because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act [21 U.S.C. 321(g)(1)(C)] because it is intended to affect the structure or any function of the body.
Moreover VMV HYPOALLERGENICS ESSENCE SIMPLE-GENTLE SKIN-SAVING TOOTHPASTE is a new drug, as defined by 201(p) of the FD&C Act [21 U.S.C. 321(p)], because there is no evidence that it is generally recognized as safe and effective for its labeled uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Conclusion
Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations.
Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.
Failure to correct these violations may also result in FDA refusing admission of articles manufactured at Skin Sciences Laboratory Inc., Unit 101 Central Business Park, Amang Rodriguez Avenue, Manggahan, Pasig City, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Under the same authority, articles may be subject to refusal of 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).
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your 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.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov or mail your reply to:
Chelsea Sealey
Compliance Officer
U.S. Food and Drug Administration
White Oak Building 51, Room 4359
10903 New Hampshire Avenue
Silver Spring, MD 20993
USA
Please identify your response with FEI 3006375239.
Sincerely,
/S/
Thomas J. Cosgrove, J.D.
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research