Audrey Z. Hathaway
- MedPark Pharmacy, LLC
2002 Medical Parkway, Sajak Pavilion Suite 170
Annapolis, MD 21401-3276
- Issuing Office:
- New Jersey District Office
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Division of Pharmaceutical Quality Operations I
10 Waterview Blvd, 3rd FL
Parsippany, NJ 07054
Telephone: (973) 331-4900
FAX: (973) 331-4969
CMS # 547639
Monday, March 5, 2018
Audrey Z. Hathaway, Pharmacist-in-Charge
MedPark Pharmacy, LLC
2002 Medical Parkway, Sajak Pavilion Suite 170
Annapolis, MD 21401-3276
Dear Dr. Hathaway:
From January 9, 2017, to March 10, 2017, U.S. Food and Drug Administration (FDA) investigators inspected your facility, MedPark Pharmacy, LLC, located at 2002 Medical Parkway, Sajak Pavilion Suite 170, Annapolis, MD 21401-3276. During the inspection, 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 March 10, 2017. FDA acknowledges receipt of your facility’s response, dated March 31, 2017. FDA also acknowledges your voluntary recall, initiated on June 1, 2017, of all sterile human and animal compounded medications within expiry. In addition, we acknowledge that you ceased sterile drug compounding on March 28, 2017. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).
A. 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. Container-closure components intended to be sterile, which you purchased pre-sterilized, were opened and stored in an unclassified area.
2. The ISO 5 core is protected by an ISO 7 antechamber, which is also part of the isolator. However, the isolator is located inside of an unclassified room that opens to the general pharmacy area. The air inside the isolator is turned off when the isolator is not in use. The core of the ISO 5 (b)(4) is exposed to the air of the unclassified room when it is opened during the weekly cleaning and disinfection and when not in use.
3. The disinfectant used to clean the interior of the ISO 5 (b)(4) is non-sterile.
4. The wipes used to clean the interior of the ISO 5 (b)(4) are not used in a manner that maintains sterility. The wipes are purchased sterile and are not individually wrapped. But the bulk package is opened and stored in an unclassified room.
5. While preparing 0.01% atropine eye drops on 01/24/2017, an operator was observed passing the sleeves of the isolator over the open sterile finished product container that was holding the 0.9% sodium chloride solution which was sterilized by filtration, thereby interrupting the flow of first air to the container.
Furthermore, FDA investigators collected environmental samples of multiple locations in your facility. Testing results of the samples identified microbial contamination in the ISO 5 aseptic processing areas, including spore-forming bacteria.
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.
B. Corrective Actions
We have reviewed your firm’s response to the Form FDA 483. We acknowledge your voluntary recall, initiated on June 1, 2017, of all sterile human and animal compounded medications within expiry. In addition, we acknowledge that you ceased sterile drug compounding on March 28, 2017.
Regarding your responses to the following observations related to insanitary conditions documented in the Form FDA 483, we are unable to fully evaluate the adequacy of your corrective actions due to some remaining concerns and lack of supportive documentation. Specifically;
- In your response to Form FDA 483 Observation 3, you state that “MedPark uses (b)(4) to clean the sterile isolator and that their cleaning procedure is one that is recommended by the manufacturer and has been shown to meet the requirements for USP General Chapter .” You also state that “MedPark Pharmacy will purchase sterile wipes packed individually to maintain each wipe’s sterility and use them prior to performing sterile production. In addition, MedPark Pharmacy will use (b)(4) on a going forward basis.” However, you firm did not establish a dateline for when the purchased of the sterile wipes will be completed and/or any interim corrective actions to be taken.797>
- In regards to the Form FDA 483 Observation 1(ii), your firm did not address the concerns of our investigators regarding the handling of pre-packaged, capped and stoppered sterile vial packs opened in an unclassified room with and without gloves. No corrective action was indicated to be implemented to avoid this occurrence.
- In response to Form FDA 483 Observation 2, you stated that “MedPark Pharmacy standards require that the isolator is fully and thoroughly cleaned and purged prior to any compounding being performed in the isolator and, to date, all tests indicate that the isolator meets USP General Chapter requirements for sterility.” We recommend you thoroughly assess your cleaning and disinfecting procedure to ensure that the ISO 5 areas are being adequately and consistently disinfected to achieve aseptic conditions for the processing of drug products intended to be sterile. 797>
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 [21 U.S.C. §353a].
Should you 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 current good manufacturing practices (CGMP) regulations.
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.
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 (15) 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 fifteen (15) days prior to resuming production of any sterile drugs in the future.
Your written notification should refer to the Warning Letter Number above (547639). Please address your reply to:
Ernest F. Bizjak
FDA/OPQ Div 1
11919 Rockville Pike
Rockville, MD 20852
If you have questions regarding the contents of this letter, please contact Ernest Bizjak, Compliance Officer, by telephone at 301-796-4081, or by email at Ernest.Bizjak@fda.hhs.gov.
Diana Amador Toro
Division Director/OPQ Division 1
New Jersey District Office