FDA Sent These 16 Warning Letters for Pharma Companies | January 2018

//FDA Sent These 16 Warning Letters for Pharma Companies | January 2018

FDA Sent These 16 Warning Letters for Pharma Companies | January 2018

By | 2018-02-05T16:39:23+00:00 February 5th, 2018|FDAzilla|

We took a snapshot of the 16 warning letters the FDA sent to pharmaceutical companies last month.  The “Violation of the Month” was failing to bear adequate directions for the drug’s intended use.

From pharmaceuticals in New Jersey, Japan, and more, here they are (starting with the most recent):

  • Daito Kasei Kogyo Co., Okayama, Japan – 2 violations:
    • Failure to ensure that, for each batch of API, appropriate laboratory tests are conducted to determine conformance to specifications.
    • Failure to completely report test results on certificates of analysis.
  • Beauty Manufacturing Solutions Corp., Coppell, Texas – 2 violations:
    • 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).
    • Failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
  • GUNA, Inc., Whitehall, PA – 1 violation:
    • Failure to make appropriate health-related claims — claims that a product will treat or cure a disease or other health condition, must be supported by competent and reliable scientific evidence at the time the claims are made.
  • Wong Lap Kwong Medicine Company Limited, Sham Shui Po, Hong Kong – 4 violations:
    • Failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22(d)).
    • Failed to ensure the identity of components, including active ingredients and excipients from various suppliers (21 CFR 211.84(d)(1) and (2)).
    • Failed to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess, and firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).
    • Failed to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of and to maintain written records of calibration checks and inspections of equipment used in the manufacture, processing, packing, and holding of a drug product (21 CFR 211.68(a)).

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  • Medicus Holistic Alternatives LLC Somersby, Australia – 1 violation:
    • “Natracet” fails to bear adequate directions for its intended uses and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
  • Soothedrawal, Inc., Acworth, GA – 1 violation:
    • “Soothedrawal Daytime Formula” and “Soothedrawal Nighttime Formula” fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
  • Healthy Healing, LLC, Eden Prairie, MN – 1 violation:
    • “Withdrawal Support” fails to bear adequate directions for its intended uses and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
  • TaperAid, Gainesville, FL – 1 violation:
    • “TaperAid” and “TaperAid Complete” fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
  • U4Life, LLC, West New York, NJ – 1 violation:
    • “Mitadone Anti-Opiate Aid Plus Extra Strength” fails to bear adequate directions for its intended uses and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
  • Nutracore Health Products, LLC, Trinity, FL – 1 violation:
    • “Opiate Detox Pro” fails to bear adequate directions for its intended uses and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
  • Choice Detox Center, Inc., Costa Mesa, CA – 1 violation:
    • “Nofeel” fails to bear adequate directions for its intended uses and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
  • Opiate Freedom Center, Eagle, ID – 1 violation:
    • ”Opiate Freedom 5-Pack” fails to bear adequate directions for its intended uses and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)).
  • CalmSupport.com, LLC, Phillipsburg, NJ – 1 violation:
    • “CalmSupport” fails to bear adequate directions for its intended uses and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
  • King Bio, Inc., Asheville, NC – 1 violation:
    • AddictaPlex fails to bear adequate directions for use, which causes the product to also be misbranded under section 502(f)(1) of the Act, 21 U.S.C. 352(f)(1).
  • Hunan Norchem Pharmaceutical Co., Changsha, China – 2 violations:
    • Failure to prepare and use production and control records for each intermediate and API batch.
    • Failure to maintain complete data derived from all laboratory tests conducted to ensure API and intermediates comply with established specifications and standards.
  • Yicheng Chemical Corporation, Changzhou, China – 3 violations:
    • Failure to package (b)(4) drugs (including (b)(4) and (b)(4)) and other drugs under appropriate conditions to avoid potential cross-contamination.
    • Failure of quality unit to review batch production records prior to distribution of an API batch.
    • Failure to maintain complete traceability of API in commercial distribution.

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