Recipient NameWilliam O. Moore
- Moore's Pharmacy Inc
101 West Sinton Street
Sinton, TX 78387-2524
- Issuing Office:
- Dallas District Office
Office of Pharmaceutical Quality Operations, Division II
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204
101 West Sinton Street
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:
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)).
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
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.
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 email@example.com..
If you have questions regarding the contents of this letter, please contact Dayna Martinez by phone at (787) 729-8608 or by email at firstname.lastname@example.org.
Acting Program Division Director
Gay Dodson, R.Ph., Executive Director
Tower 3, Suite 600
333 Guadalupe Street
Austin, Texas 78701
Karen Tannert, R.Ph., MPH
Drugs andMedical Device Group Policy
8407 Wall Street
Austin, Texas 75754
Amanda Lawrence, Pharmacist-in-Charge
200 S Rachal Street