- Delivery Method:
- VIA Electronic Mail
Recipient NameJennifer Yoakum
Recipient TitleCo-Owner and Pharmacist-In-Charge
- Med Shop Total Care, Inc.
470 E Loop 281
Longview, TX 75605-7939
- Issuing Office:
- Office of Pharmaceutical Quality Operations, Division II
March 18, 2022
Dear Ms. Yoakum:
From July 7, 2021, to July 27, 2021, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Med Shop Total Care, Inc., located at 470 E Loop 281, Longview, TX 75605. During the inspection, the investigator 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 July 27, 2021. FDA acknowledges receipt of your facility’s response, dated August 17, 2021. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (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 practice (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)].
B. 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. For example, the investigator observed:
1. You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 aseptic processing area.
2. An operator placed their gloved hands outside the ISO 5 aseptic processing area to retrieve supplies without sanitizing their gloved hands before re-entry into the ISO 5 hood.
3. Your firm failed to establish an adequate contact time for a disinfecting agent used in your aseptic processing areas.
4. A brownish residue on the protective screen of the HEPA filter within your ISO 5 aseptic processing area.
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.
C. Corrective Actions
We have reviewed your firm’s response to the Form FDA 483.
Regarding your responses related to the insanitary conditions, some of your corrective actions appear adequate; however, the following corrective actions appear deficient:
1. Regarding your response to Observation 1, your response is inadequate. Any microbial contamination in the ISO 5 area is considered an insanitary condition. Any microbial contamination within the ISO 5 area is a serious concern and upon recovery, your firm should immediately assess the impact on drug products produced. This assessment should include a thorough evaluation of how contamination could have entered this critical area, and over what period of time the contamination could have existed, as well as drug products that remain on the market that could be affected.
In addition, in response to Observation 7, we acknowledge your immediate recall upon notification from your third-party testing laboratory of a sterility failure for a bulk intermediate. We also acknowledge your statement that all recovered prescriptions that contained the lot in question “…were tested for sterility and test results showed that all were sterile.” Please note, microbial contamination, when present, is not uniformly distributed within a batch; therefore, it may not be identified in a sterility test. Compounding facilities producing drug products intended to be sterile under insanitary conditions should not rely upon or cite a passing sterility test result as an indication of product sterility.
2. In response to Observation 5, we acknowledge your statement, “In an effort to reduce movement in and out of the hood, we are currently testing computer keyboards that are designed for clean room areas, and which may be kept inside the hood, so that logging information can be conducted during our processing.” However, your response is inadequate as it does not indicate a timeframe for implementation or any appropriate interim actions to address this concern.
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.
FDA strongly recommends that your management 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 processing 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 any violations 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.
You should take prompt action to correct any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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 address any violations. Please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. If you believe that your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.
Your written notification should refer to the Warning Letter Number above (Case #628182). Please electronically submit your signed reply on your firm’s letterhead to ORA PHARM2 Acting DCB at email@example.com and firstname.lastname@example.org.
If you have questions regarding the contents of this letter, you may contact Mr. Thao Ta, Compliance Officer, via phone at 214-253-5217 or e-mail at email@example.com.
Monica R. Maxwell
Program Division Director
Office of Pharmaceutical Quality Operations,
cc: VIA ELECTRONIC MAIL
Tim Tucker, Pharm.D., Executive Director/Secretary
Texas State Board of Pharmacy
333 Guadalupe, Suite #3-500
Austin, Texas 78701