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WARNING LETTER

Well Care Compounding Pharmacy MARCS-CMS 521007 —


Delivery Method:
Certified Mail

Recipient:
Recipient Name
Marcelino P. Casal
Well Care Compounding Pharmacy

3430 E Tropicana Avenue, Suite 9

Las Vegas, NV 89121-7345
United States

Issuing Office:
San Francisco District Office

United States


 

  

Black HHS-Blue FDA Logo

 

 

San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
 
Telephone: (510) 337-6700
Fax: (510) 337-6701
 
 

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
 
 
WARNING LETTER
 
 
 
March 29, 2017
 
CMS# 521007
 
 
Well Care Discount Pharmacy, LLC dba Well Care Compounding Pharmacy
Marcelino P. Casal, President/CEO
3430 E Tropicana Avenue, Suite 9
Las Vegas, NV 89121-7345
 
Dear Dr. Casal:
 
 
From May 2, 2016, to May 12, 2016, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Well Care Compounding Pharmacy, located at 3430 E Tropicana Avenue, Suite 9, Las Vegas, Nevada 89121-7345.  During the inspection, the investigators noted that drug products you produced failed to meet the conditions of section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353a] for exemption from certain provisions of the FDCA.  In addition, the investigators noted serious deficiencies in your practices for producing sterile drug products, which put patients at risk.
 
FDA issued a Form FDA 483 to your firm on May 12, 2016. FDA acknowledges receipt of your facility’s response, dated May 24, 2016.  FDA also acknowledges the statement in your response letter indicating that your facility has decided to “stop performing STERILE COMPOUNDING services immediately.”  Additionally, FDA acknowledges your firm’s voluntary recall, initiated on May 10, 2016, of all sterile products distributed from January 1, 2016, to May 2, 2016 due to lack of sterility assurance. Based on this inspection, it appears that you produced drug products that violate the FDCA.
 
A.  Compounded Drug Products Under the FDCA
 
Section 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FDCA: compliance with current good manufacturing practices (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].1 Receipt of valid prescriptions for individually- identified patients is one of the conditions for the exemptions under section 503A.
 
B.  Failure to Meet the Conditions of Section 503A
 
During the inspection, the FDA investigators noted that drug products produced by your firm failed to meet the conditions of section 503A. For example, the investigators noted that your firm did not receive valid prescriptions for individually-identified patients for a portion of the drug products you produced.
 
Therefore, you compounded drug products that do not meet the conditions of section 503A and are not eligible for the exemptions in that section from the FDA approval requirement of section 505 of the FDCA, the requirement under section 502(f)(1) of the FDCA that labeling bear adequate directions for use, and the requirement of compliance with CGMP under section 501(a)(2)(B) of the FDCA. In the remainder of this letter we refer to your drug products that do not qualify for the exemptions under section 503A as the “ineligible drug products.”
 
Specific violations are described below.
 
C.  Violations of the FDCA
 
Adulterated Drug Products
 
The FDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section
501(a)(2)(A) of the FDCA. For example, the investigators observed that:
 
1.    Your firm performed poor aseptic practices, including:
 
a.  An operator that (b)(4) by placing gloved hands directly over open sterile containers.
 
b.  An operator stoppering product vials and touching product contact surfaces of the sterile stoppers with their gauntlet gloves during sterile drug production.
  
2.    Your (b)(4) was located on a table of laminated wood with an exposed wood cut- out, which may harbor contamination and is difficult to clean and disinfect.
 
3.    Your (b)(4) ceiling tiles had numerous unsealed gaps between the ceiling tiles surrounding the (b)(4) filter and above the (b)(4).
 
4.    Your (b)(4) was visibly dirty. Specifically, the main chamber had reddish/orange spots on the interior surface, crystal-like residues along the interior of the viewing windows, and a yellowish debris-like material on (b)(4).
 
5.    Your firm used non-sterile wipes as part of your disinfection program for the aseptic processing area.
 
6.    Glassware used for sterile drug processing was placed in a (b)(4) These parameters are inadequate for (b)(4).
 
7.    Your firm failed to demonstrate through appropriate studies that your (b)(4) is able to provide adequate protection of the (b)(4) in which sterile products are produced.
 
Furthermore, the manufacture of the ineligible drug products is subject to FDA’s CGMP regulations, Title 21, Code of Federal Regulations (CFR), parts 210 and 211. The FDA investigators observed significant CGMP violations at your facility, causing the ineligible drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations included, for example:
 
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))
 
2.    Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions. (21 CFR 211.42(c)(10)(v))
 
3.    Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas. (21 CFR 211.42(c)(10)(iv))
 
4.    Your firm failed to ensure that floors, walls and ceilings in the aseptic processing areas are smooth and/or hard surfaces that are easily cleanable. (21 CFR 211.42(c)(10)(i))
 
5.    Your firm failed to clean and, where indicated by the nature of the drug, sterilize and process container closures to remove pyrogenic properties to assure they are suitable for their intended use. (21 CFR 211.94(c))
 
6.    Your firm does not have, for each batch of drug product purporting to be sterile and/or pyrogen-free, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product. (21 CFR 211.167(a))
 
7.    Your firm failed to ensure that its drug product bore an expiration date that was supported by appropriate stability testing. (21 CFR 211.137(a))
 
Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.
 
Unapproved New Drug Products
 
You do not have any FDA-approved applications on file for the ineligible drug products that you compounded.2  Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. § 331(d)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug.  Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.
 
Misbranded Drug Products
 
The ineligible drug products you compounded are intended for conditions not amenable to self- diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses.3  Accordingly, these ineligible drug products are misbranded under section 502(f)(1) of the FDCA. The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA.  It is also a prohibited act under section 301(k) of the FDCA to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.
 
D.  Corrective Actions
 
We have reviewed your firm’s response to the Form 483. We acknowledge your May 24, 2016, action to cease sterile compounding operations and your May 10, 2016, action to voluntarily recall all sterile products distributed from January 1, 2016, to May 2, 2016, due to concern over lack of sterility assurance.
 
Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A, including the condition on receipt of a prescription for an identified individual patient prior to compounding and distributing drug products.
 
Should you continue to compound and distribute drug products that do not meet the conditions of section 503A, the compounding and distribution of such drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use,
and the drug CGMP regulations. Before doing so, you must comply with the requirements of section 505 and 502(f)(1) and fully implement corrections that meet the minimum requirements of the CGMP regulations.4
 
In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FDCA.  If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that your drugs are neither adulterated nor misbranded. [See 21 CFR 210.1(b), 21 CFR 200.10(b)].
 
FDA strongly recommends that if you decide to resume production of sterile drugs, your management first undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance materials, and systems.  In particular, this review should assess your aseptic processing operations.  A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
 
E.  Conclusion
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations.  It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
 
If you decide to resume sterile operations, you should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
 
Within fifteen working days of receipt of this letter, please notify this office in writing if you have taken any specific steps to correct the violations cited in this letter, or you may inform us that you do not intend to resume production of sterile drugs.  If you intend to resume production of sterile drugs in the future, please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.  If you do not believe that the products discussed above violated the FDCA, include your reasoning and any supporting information for our consideration. In addition to taking appropriate corrective actions, you should notify this office 15 days prior to resuming production of any sterile drugs in the future.
 
Your written notification should refer to the Warning Letter Number above (CMS# 521007). Please address your reply to:
 
Lawton W. Lum, Director of Compliance Branch
San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94505-7070
 
If you have questions regarding the contents of this letter, please contact Lance De Souza at 510-337-6873 or via email at  Lance.DeSouza@fda.hhs.gov. 
 
Sincerely,
/S/ 
Darla R. Bracy
Acting District Director
San Francisco District
 
 
cc: Larry L. Pinson, Pharm.D. Executive Secretary
Nevada State Board of Pharmacy
431 W Plumb Lane
Reno, NV 89509
 
__________________________
1 We remind you that there are conditions other than those discussed in this letter that must be satisfied to qualify for the exemptions in section 503A of the FDCA.
2 The specific products made by your firm are drugs within the meaning of section 201(g) of the Act, [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) [21 U.S.C. 321(p)] of the FDCA because they are not generally recognized as safe and effective for their labeled uses.
3 Your ineligible drug products are not exempted from the requirements of section 502(f)(1) of the FDCA by regulations issued by the FDA (see, e.g., 21 CFR 201.115).
4 In this letter we do not address whether your proposed corrective actions would resolve the CGMP violations noted above.