1. Inadequate area separation risks contamination in aseptic drug processing.

Root Cause:
Lack of procedural adherence and inadequate documentation practices during aseptic batch manufacturing.
Corrective Actions:
Update and enforce strict standard operating procedures (SOPs) for batch manufacturing with explicit documentation requirements.
Preventive Actions:
Conduct regular training for personnel on SOP compliance and the importance of accurate documentation.
Reference FDA 483:
Company Name: Brassica Pharma Pvt Ltd
Issue Date: 2024-01-19
Inspection Dates: 15 Jan 2024 to 19 Jan 2024
Investigators: Anastasia M Shields, Justin A Boyd

2. Batch components are not double-checked by a second person during addition.

Root Cause:
Inadequate process controls and supervision in the component addition step.
Corrective Actions:
Revise SOPs to emphasize the importance of dual verification in batch manufacturing.
Preventive Actions:
Regularly train all personnel involved in batch manufacturing on updated SOPs and conduct routine performance reviews.
Reference FDA 483:
Company Name: FUJINOMIYA FACTORY OF TERUMO CORP
Issue Date: 2023-05-19
Inspection Dates: 15 May 2023 to 19 May 2023
Investigators: Irina Gaberman, Brandon L Mariner

3. Manufacturing equipment is not properly designed for use or maintenance.

Root Cause:
Inadequate integration of equipment qualification within the batch manufacturing process.
Corrective Actions:
Ensure all batch manufacturing equipment is qualified and logged before batch initiation.
Preventive Actions:
Incorporate equipment qualification checks into the batch record review process.
Reference FDA 483:
Company Name: Orly International, Inc.
Issue Date: 2022-12-20
Inspection Dates: 12 Dec 2022 to 20 Dec 2022
Investigators: Crystal Monroy, Carolina D Vasquez

4. Components for drug manufacturing are not properly weighed or measured.

Root Cause:
Lack of procedural control in the documentation process for recording critical component amounts, indicating a potential systematic issue in batch record management and adherence to SOPs.
Corrective Actions:
Update the batch manufacturing records to include mandatory fields for specifying and recording the amount of (b)(4) solution used. Ensure that all current and future batches are documented as per the updated protocol.
Preventive Actions:
Implement training sessions for all pertinent staff on updated batch record procedures. Regular audits should be scheduled to ensure compliance with the new documentation requirements. Create a routine monitoring system to verify that all required fields in batch records are completed accurately.
Reference FDA 483:
Company Name: Torrent Pharmaceuticals Limited
Issue Date: 2023-12-11
Inspection Dates: 05 Dec 2023 to 11 Dec 2023
Investigators: Yvins Dezan

5. Inadequate written procedures for production and process controls.

Root Cause:
Deficient batch manufacturing oversight, releasing products without confirming process validation and consistency.
Corrective Actions:
Withhold distribution of all manufactured lots until appropriate validation is completed. Implement oversight mechanisms ensuring no batches are released without validation confirmation.
Preventive Actions:
Establish robust batch review protocols, incorporating validation checks before any batch release approval. Train staff on new batch manufacturing and release procedures.
Reference FDA 483:
Company Name: Stokes Healthcare Inc. dba Epicur Pharma
Issue Date: 2023-10-25
Inspection Dates: 26 Sep 2023 to 25 Oct 2023
Investigators: Christina K Theodorou, Yoriann M Cabrera Bartolomei, Ruben C Quintana

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6. Intended to sterilize the final product is inadequate.

Root Cause:
Failure to adhere to manufacturing protocols and inadequate review of production logs.
Corrective Actions:
Review and quarantine all affected batches. Conduct an immediate risk assessment for previously distributed products. Notify medical professionals and end-users of potential contamination risks.
Preventive Actions:
Implement stricter batch review protocols, including cross-verification by a quality assurance team. Enhance traceability and logging of all batch-related materials and steps.
Reference FDA 483:
Company Name: Revive Rx LLC dba Revive Rx Pharmacy
Issue Date: 2022-05-04
Inspection Dates: 12 Apr 2022 to 04 May 2022
Investigators: Camerson E Moore

7. Contamination prevention procedures in sterile drugs are inadequate.

Root Cause:
Power failure incidents and insufficient control measures during batch manufacturing leading to exposure of the product to non-sterile environments.
Corrective Actions:
Reinforce the electrical systems to prevent power failures and establish emergency procedures to maintain sterile conditions during power interruptions.
Preventive Actions:
Install backup power systems and conduct regular drills to ensure smooth transition during power failures without compromising sterile conditions.
Reference FDA 483:
Company Name: Cipla Limited
Issue Date: 2023-02-17
Inspection Dates: 06 Feb 2023 to 17 Feb 2023
Investigators: Saleem A Akhtar, Jose E Melendez

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