Firm Record
K.C. Pharmaceuticals, Inc. findings history
8 findings from 2 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Aseptic processing and sterility assuranceDocumentation and recordsComplaint and recall handlingLaboratory and QC controlsDeviation, CAPA, and investigation
Published inspection documents
2026-08-18
US FDA
5 findingsDocumentation and records · Complaint and recall handling · Laboratory and QC controls · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit (21 CFR 211.22(d)). Complaint Handling Your QU did not adequately ensure procedures were established and followed. For example, your procedure for customer complaints and inquiries is inadequate. Your approach to determining severity and adverse events resulted in delayed and incomplete investigations. Additionally, investigations were based on the client and not the severity of the complaint. Also, adequate complaint investigations were not completed in a timely manner. In your response, you commit to revising your procedure and reviewing past complaints to ensure serious events are properly investigated. Your response is inadequate. You did not provide the status of open complaint investigations or whether additional complaints have been received since the close of the inspection. Stability Program Your QU failed to ensure stability testing was conducted according to your program procedures. Your firm missed stability time points, missed stability tests, or performed incorrect tests on batches placed into your stability program. In your response, you acknowledge the lack of proper QU oversight of the stability program. You commit to performing an impact assessment with the assistance of external consultants and revising your stability program procedure. Your response is inadequate. You did not provide details on how the impact of incomplete stability testing will be assessed for product batches that have been distributed to the US. market. In response to this letter, provide: A comprehensive, independent review of your overall complaint system, including a retrospective review of all complaints for the last three years from the initial date of the inspection, with an assessment that includes but is not limited to: o Nature of complaint, and potential associated risk. o Date of first notification and subsequent contacts with complainant. o Timing and sufficiency of followups with complainant to obtain photographs and the complaint sample, as well as to obtain any additional contextual information. Determine relevant complaint samples were available and extent of efforts to obtain the complaint sample. If insufficient attempts were made, identify the root cause(s) for not adequately pursuing their return. o Review of long-term history for similar or same defects. o Identification of potential causes of the defect that led to the complaint, including evaluation whether the scientific justification and evidence relating to the identified root cause(s) were adequately documented. In the event a complaint was attributed to factors outside of the firm’s control (e.g., user error), assess the strength of this determination and whether it was based on conclusive or inconclusive information. o CAPA steps taken, including but not limited to manufacturing/quality improvements (e.g., manufacturing operation, raw materials, supplier, quality control), as well as recalls or heightened quality surveillance (additional testing/examinations, adding batch to stability program). o For all complaint investigations found by the retrospective review to be deficient due to insufficient root cause or CAPA, perform a thorough analysis of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, out-of-specification history, batch failure history). o Based upon this independent review, provide a comprehensive assessment of the complaint system that identifies all deficiencies and needed improvements. o The status of your review of open complaint investigations and whether additional complaints have been received since the procedure has been revised. A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to: o Stability indicating methods. o Stability studies for each drug product in its marketed container-closure system before distribution is permitted. o An ongoing program in which representative batches of each product are added each year to the program to determine whether the shelf-life claim remains valid. o Detailed definition of the specific attributes to be tested at each station (timepoint), as part of a program that encompasses each quality attribute that may change over the product shelf-life. o All procedures that describe these and other elements of your remediated stability program. Your firm’s quality systems are inadequate. See FDA’s guidance document, Quality Systems Approach to Pharmaceutical CGMP Regulations , for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download. Quality Unit Authority Your inspectional history indicates that your QU is not able to fully exercise its authority and/or responsibilities. Your firm must provide the QU with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality. Drug Production Suspended We acknowledge your commitment to suspend production of all OTC (b)(4) drug products at this facility. If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPA.…
2023-08-29
US FDA
3 findingsAseptic processing and sterility assurance Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). Cleaning validation studies for aseptic processing line (b)(4) , used to manufacture multiple formulations of ophthalmic drug products, has not been completed. For example, the (b)(4) compounding tank and product transfer line (b)(4) , used to formulate bulk ophthalmic drugs for filling on line (b)(4) , did not have recovery studies or limits of…
About this page
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
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