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WARNING LETTER

Moore's Pharmacy Inc MARCS-CMS 544530 —


Recipient:
Recipient Name
William O. Moore
Moore's Pharmacy Inc

101 West Sinton Street

Sinton, TX 78387-2524
United States

Issuing Office:
Dallas District Office

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
Office of Pharmaceutical Quality Operations, Division II
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204

 

January 16, 2018
 
CMS Case# 544530
WARNING LETTER
VIA UPS EXPRESS
 
William O. Moore, Owner
Moore’s Pharmacy, Inc.
101 West Sinton Street
Sinton, Texas 78387-2524
 
Mr. Moore:
 
From August 25, 2016, to September 1, 2016, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Moore’s Pharmacy, Inc., located at 200 S Rachal Street, Sinton, Texas 78387-2524. During the inspection, the investigator 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 investigator noted serious deficiencies in your practices for producing drug products, which put patients at risk.
 
FDA issued a Form FDA 483 to your firm on September 1, 2016. FDA acknowledges receipt of your facility’s response, dated September 20, 2016. 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 investigator noted that drug products produced by your firm failed to meet the conditions of section 503A. For example, the investigator 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 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 exemptions under section 503A as the “ineligible drug products.”
 
Specific violations are described below.
 
C.  Violations of the FDCA
 
Adulterated Drug Products

The FDA investigator noted that drug products 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 [21 U.S.C. § 351(a)(2)(A)]. For example, the investigator observed a dead cockroach inside your drug production room. In addition, a hole in the ceiling of your compounding room exposed the insulation and the uncontrolled warehouse from above. Moreover, gaps were observed under the main door of the drug production room, and at the bottom of a door where capsules are produced leading to the uncontrolled warehouse.

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 investigator 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 maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition to keep the buildings used in the manufacture, processing, packing, or holding of a drug product free of infestation by rodents, birds, insects, and other vermin (21 CFR 211.56(a)).

2. Your firm 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 211.192).

3. 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)).
 
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.2 Accordingly, these ineligible drug products are misbranded under section 502(f)(1) of the FDCA. It is 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 dated September 20, 2016.

Regarding the insanitary condition observations in the Form FDA 483, we are unable to fully evaluate your corrective actions due to lack of adequate supporting documentation. Specifically, you stated that you conducted a full cleaning of the non-sterile compounding lab. However, you did not provide documentation of your pest control service agreement and plan. In addition, you did not include documentation to confirm that personnel training occurred on SOP 3.030 “Pest Control” and SOP 3.020 “Cleaning and Maintenance of the Non-Sterile Compounding Area” for our review.

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 of the FDCA, including the condition on receipt of a prescription for an identified individual patient prior to compounding and distributing drug products.

In addition, regarding issues related to the conditions of section 503A of the FDCA, you should address in your response to this letter whether your firm is now receiving valid prescriptions for individually-identified patients for a portion of the drug products you produce.

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 502(f)(1) and fully implement corrections that meet the minimum requirements of the CGMP regulations.3
 
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 drugs you introduce into interstate commerce are neither adulterated nor misbranded. [See 21 CFR 210.1(b), 21 CFR 200.10(b)].

FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance materials, and systems. A third-party consultant with relevant 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.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations. Please include an explanation of each step being taken to prevent the recurrence of the violations, as well as copies of related documentation. If you do not believe that the products discussed above are in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction.

Your written notification should refer to the Warning Letter Number above (CMS Case 544530). Please address your reply to John W. Diehl, Director, Compliance Branch, at the FDA address provided. In addition, please submit a signed copy of your response to john.diehl@fda.hhs.gov..

If you have questions regarding the contents of this letter, please contact Dayna Martinez by phone at (787) 729-8608 or by email at dayna.martinez@fda.hhs.gov.

 
Sincerely,
/S/
Monica R. Maxwell
Acting Program Division Director
Office of Pharmaceutical Quality
Operations, Division II

 
CC:
Gay Dodson, R.Ph., Executive Director
Texas State Board of Pharmacy
William P. Hobby Building
Tower 3, Suite 600
333 Guadalupe Street
Austin, Texas 78701

Karen Tannert, R.Ph., MPH
Drugs andMedical Device Group Policy
Texas DSHS
8407 Wall Street
Austin, Texas 75754

Amanda Lawrence, Pharmacist-in-Charge
Moore’s Pharmacy, Inc.
200 S Rachal Street
Sinton, Texas 78387 
 
____________________________________ 
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 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).
3 In this letter we do not address whether your proposed corrective actions would resolve the CGMP violations noted above