Happi staff09.18.19
The US Food and Drug Administration (FDA) has published details of a warning letter to Herbert Fisk Johnson on June 11, 2019 regarding an inspection at SC Johnson Professional, Inc. (formerly Deb USA, Inc.) in Stanley, NC, from October 22 to 30, 2018. The warning letter summarizes what FDA calls significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (see 21 CFR, parts 210 and 211) and requirements for registration and listing of drug products (see Section 510(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) and 21 CFR part 207). According to FDA, because methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, the companhy's drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA, in its letter. said it reviewed SC Johnson’s Nov. 20, 2018 response in detail and acknowledge receipt of your subsequent correspondence.
During the inspection, FDA investigators observed specific violations related to CGMP.
FDA said the firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures applicable to the quality control unit (21 CFR 211.22(d)).
Investigators documented that the company quality unit (QU) failed to follow the firm’s procedures, according to FDA. For example, failure to ensure every drug product batch is released only when satisfactory product quality testing is completed.
FDA said SC Johnson released antimicrobial hand soaps and hand sanitizers for distribution before reviewing and approving microbiology test results. FDA also noted that QU did not perform its basic responsibility of ensuring that drug products possessed their required quality attributes at the time of release and distribution. Further, it said the facility also did not initiate investigations into out-of-specification (OOS) test results “in a timely manner,” as required by the firm’s procedure.
FDA said the company initiated the investigation into an OOS assay test result for AntiBac FOAM, lot 048994, approximately two months after the lot was released. According to FDA, SCJ’s response indicated you have improved procedures and trained employees to ensure completion of chemical and microbiological testing before releasing drug products, however it found that response inadequate “ because you did not address the fundamental failure of the QU to perform its batch disposition function, identify the root cause(s), and ensure full remediation of QU authorities and responsibilities.”
FDA has asked the company to provide a comprehensive assessment and corrective action and preventive action (CAPA) to ensure QU is given the authority and resources to effectively function.
FDA stated that the firm 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)).
FDA's letter also allegdes that SCJ failed to establish and follow required laboratory control mechanisms (21 CFR 211.160(a)) and failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).
FDA’s inspection found instances in which the firm overwrote electronic testing data, discarded original testing records, and failed to report OOS laboratory test results. FDA noted that the company failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)). FDA said its inspection found that products were released without appropriate microbiological testing, and that the firm acknowledged that drug products are routinely released for distribution before receiving, reviewing, and approving microbiological quality testing.
Based upon the nature of the violations identified, FDA said it strongly recommend that the firm engage a consultant qualified as set forth in 21 CFR 211.34 to assist in meeting CGMP requirements.
FDA also reviewed the listing information provided for Kindest Kare Antimicrobial Foam Handwash, NDC 11084-808 and found inaccurate information. FDA said the company has failed to address this listing deficiency detailed in FDA’s letter to your company on February 26, 2018. A data removal notification was also sent to your company on April 12, 2018, and at that time, the listing data was removed from the online NDC Directory. FDA asked SCJ to promptly correct this deficiency.
A review of the listing for Kindest Kare Antimicrobial Foam Handwash, NDC 11084-808, revealed that the active ingredients do not match between the labeling and the electronic listing file; specifically, the labeling refers to triclosan 0.75% as the active ingredient, while the active ingredient listed in the SPL is alcohol 62 mg in 100 ml.
FDA, in its letter. said it reviewed SC Johnson’s Nov. 20, 2018 response in detail and acknowledge receipt of your subsequent correspondence.
During the inspection, FDA investigators observed specific violations related to CGMP.
FDA said the firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures applicable to the quality control unit (21 CFR 211.22(d)).
Investigators documented that the company quality unit (QU) failed to follow the firm’s procedures, according to FDA. For example, failure to ensure every drug product batch is released only when satisfactory product quality testing is completed.
FDA said SC Johnson released antimicrobial hand soaps and hand sanitizers for distribution before reviewing and approving microbiology test results. FDA also noted that QU did not perform its basic responsibility of ensuring that drug products possessed their required quality attributes at the time of release and distribution. Further, it said the facility also did not initiate investigations into out-of-specification (OOS) test results “in a timely manner,” as required by the firm’s procedure.
FDA said the company initiated the investigation into an OOS assay test result for AntiBac FOAM, lot 048994, approximately two months after the lot was released. According to FDA, SCJ’s response indicated you have improved procedures and trained employees to ensure completion of chemical and microbiological testing before releasing drug products, however it found that response inadequate “ because you did not address the fundamental failure of the QU to perform its batch disposition function, identify the root cause(s), and ensure full remediation of QU authorities and responsibilities.”
FDA has asked the company to provide a comprehensive assessment and corrective action and preventive action (CAPA) to ensure QU is given the authority and resources to effectively function.
FDA stated that the firm 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)).
FDA's letter also allegdes that SCJ failed to establish and follow required laboratory control mechanisms (21 CFR 211.160(a)) and failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).
FDA’s inspection found instances in which the firm overwrote electronic testing data, discarded original testing records, and failed to report OOS laboratory test results. FDA noted that the company failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)). FDA said its inspection found that products were released without appropriate microbiological testing, and that the firm acknowledged that drug products are routinely released for distribution before receiving, reviewing, and approving microbiological quality testing.
Based upon the nature of the violations identified, FDA said it strongly recommend that the firm engage a consultant qualified as set forth in 21 CFR 211.34 to assist in meeting CGMP requirements.
FDA also reviewed the listing information provided for Kindest Kare Antimicrobial Foam Handwash, NDC 11084-808 and found inaccurate information. FDA said the company has failed to address this listing deficiency detailed in FDA’s letter to your company on February 26, 2018. A data removal notification was also sent to your company on April 12, 2018, and at that time, the listing data was removed from the online NDC Directory. FDA asked SCJ to promptly correct this deficiency.
A review of the listing for Kindest Kare Antimicrobial Foam Handwash, NDC 11084-808, revealed that the active ingredients do not match between the labeling and the electronic listing file; specifically, the labeling refers to triclosan 0.75% as the active ingredient, while the active ingredient listed in the SPL is alcohol 62 mg in 100 ml.
