Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm582795.htm
Timestamp: 2019-01-23 04:57:28
Document Index: 180807909

Matched Legal Cases: ['§ 353', '§ 351', '§ 352', '§ 355', '§ 351', 'arts 210', '§ 201', 'art 211']

Abbott's Compounding Pharmacy, Inc. 4/4/17
CMS# 506776
John Garica, Pharmacist/Owner
C/o: Tony J. Park, PharmD, JD, Attorney at Law
CPL- California Pharmacy Lawyers
2855 Michelle Drive, Suite 180
From December 29, 2015, to January 8, 2016, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of Abbott's Cornpounding Pharmacy, located at 2320 Woolsey St, Berkeley, CA 94705-1973.
During the inspection, the investigators noted that you were not receiving valid prescriptions for individually-identified patients for a portion of the drug products you were producing. In addition, the investigators observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, our investigators observed that the underside of your aseptic processing work surface (ISO 5 area) consisted of exposed plywood and fiber board that had significant discoloration. Our investigators observed multiple gaps around the edges of your plastic panel cleanroom walls where "hook-and-loop" fasteners had become detached, which could allow unclassified air from the surrounding environment into the cleanroom. Our investigators also observed poor aseptic practices, including an operator not disinfecting his gloves or materials prior to introducing them into the ISO 5 area from the ISO 7 area. In addition, your firm used an expired sporicidal agent to disinfect your aseptic processing area. Furthermore, your firm failed to demonstrate through appropriate studies that your hoods are able to provide adequate protection of the ISO 5 areas in which sterile products are processed. Therefore, your products may be produced in an environment that poses a significant contamination risk.
FDA investigators collected environmental samples of multiple locations in your facility, including the aseptic processing areas. Testing results of the samples identified microbial contamination in the aseptic processing areas, including spore-forming bacteria.
FDA issued a Form FDA 483 to the firm on January 8, 2016. FDA acknowledges receipt of your facility's response to the Form FDA 483, dated February 1, 2016, and your firm's actions on January 15, 2016, to suspend sterile compounding operations until adequate corrective actions have been implemented and to voluntarily recall all sterile drug products within expiry.
Section 503A of the FDCA [21 U.S.C. § 353a] describes the conditions under which certain compounded human drug products may qualify for exemptions from three sections of the FDCA: Compliance with current good manufacturing practice (CGMP) requirements, section 501(a)(2)(B) of the FDCA [21 U.S.C.§ 351(a)(2)(B)]; labeling with adequate directions for use section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)]; and FDA approval prior to marketing of the FDCA, section 505 [21 U.S.C. § 355]. Receipt of valid prescriptions for individually­ identified patients is one of the conditions necessary to qualify for the exemptions under section 503A.
During the FDA inspection, the investigators observed that the firm did not receive valid prescriptions for individually-identified patients for a portion of the drug products you produce. Accordingly, the drugs compounded without valid prescriptions for individually-identified patients are not entitled to the exemptions in section 503A.
In addition, we remind you that there are other conditions that must be satisfied to qualify for the exemptions in section 503A of the FDCA.1
In addition, drug products that are intended or expected to be sterile were prepared, packed, or held under insanitary conditions whereby they may have been contaminated vvith filth, or rendered injurious to health, causing them to be adulterated within the meaning of section 501(a)(2)(A) of the FDCA [21 U.S.C. § 351(a)(2)(A)]. Furthermore, because the firm manufactured and distributed a portion of its drugs without valid prescriptions for individually­ identified patients, the manufacture of such drugs is subject to FDA's CGMP regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations (CFR), Parts 210 and 211. The FDA investigators observed significant CGMP violations at the facility, causing such drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA.
The drug products that you compound without obtaining valid prescriptions for individually­ identified patients are intended for conditions that are 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, causing them to be misbranded under section 502(f)(1) of the FDCA, and they are not exempt from the requirements of section 502(f)(1) of the FDCA [see,e.g., 21 CFR § 201.115].
Additionally, the FDA investigators noted that drug products in your facility that were intended orexpected 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 the drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, our investigators observed that the underside of your aseptic processing work surface (ISO 5 area) consisted of exposed plywood and fiber board that had significant discoloration. Our investigators observed multiple gaps around the edges of your plastic panel cleanroom walls where "hook-and-loop" fasteners had become detached, which could allow unclassified air from the surrounding environment into the cleamoom. Our investigators also observed poor aseptic practices; including an operator not disinfecting his gloves or materials prior to introducing them into the ISO 5 area from the ISO 7 area. In addition, your firm used an expired sporicidal agent to disinfect your aseptic processing area. Furthermore, your firm failed to demonstrate through appropriate studies that your hoods are able to provide adequate protection of the ISO 5 areas in which sterile products are processed.
2. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination bf drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
4. Your firm failed to adequately design the facility with adequate separation or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(b)).
5. Your firm failed to establish an adequate air supply filtered through high-efficiency particulate air filters under positive pressure in the aseptic processing areas (21 CFR 211.42(c)(10)(iii)).
7. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing area (21 CFR 211.42(c)(10)(iv)).
FDA acknowledges the firm's commitment, as documented in a letter dated December 31, 2015, to discontinue compounding sterile products for office use, and the firm's actions on January 15, 2016, to suspend sterile compounding operations until adequate corrective actions have been implemented and to voluntarily recall all sterile drug products within expiry. Additionally, we have reviewed the corrective actions described in the firm's February 1, 2016, response to the Form FDA 483. Although several of the corrective actions appear adequate, others are deficient. For example, the letter dated December 31, 2015, committed only to stop providing non-patient­ specific sterile products. As described above, receipt of valid prescriptions for individually­ identified patients is one of the conditions necessary to qualify for the exemptions under section 503A. This condition applies to all compounded products, whether sterile or non-sterile.
If you were to continue to manufacture and distribute drug products without valid prescriptions for individually-identifiedpatients, the manufacture of such drugs would be subject to FDA's drug CGMP regulations, among other requirements described above, and, before doing so, you should fully implement corrections that meet the minimum requirements of 21 CFR Part 211 to provide assurance that the drug products produced by your firm conform to the basic quality standards that ensure safety, identity, strength, quality, and purity. As indicated above, such drug products would also be subject to new drug approval requirements in section 505 and the requirement to be labeled with adequate directions for use in section 502(f)(l),among other requirements of the FDCA.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. 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 are in violation of 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 working days prior to resuming production of any sterile drugs in the future. Your written notification should reference the unique identifier 506776 and be addressed to:
If you have questions regarding any issues in this letter, please contact Mr. Lance De Souza via email at Lance.DeSouza@fda.hhs.gov or by phone at (510) 337-6873.
Acting San Francisco District Director