| Jun 19, 2023 | Drugs · Drug Quality Assurance | 5 cited references- 21 CFR 211.180(e)(2). Items to cover on annual reviews Written procedures are not followed for evaluations done at least annually and including provisions for a review of recalls, returned or salvaged drug products and investigations conducted for each drug product.
- 21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
- 21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.
- 21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
- 21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in current good manufacturing practices.
| Voluntary Action Indicated (VAI) |
| Dec 2, 2021 | Drugs · Drug Quality Assurance | 8 cited references- 21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
- 21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.
- 21 CFR 211.130(e). Packaging line inspection after use Inspection of the labeling facilities is not done after use to assure that materials not suitable for subsequent operations have been removed.
- 21 CFR 211.180(b). Record maintenance 1 year (except exempt OTC) All records of production, control and labeling associated with a batch of drug product were not maintained at least one (1) year after the expiration date.
- 21 CFR 211.180(e)(2). Items to cover on annual reviews Written procedures are not established and followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product.
- 21 CFR 211.125(a). Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.
- 21 CFR 211.182. Written records kept in individual logs Written records of major equipment use are not included in individual equipment logs.
- 21 CFR 211.198(b)(2). Complaint Investigation/Follow-Up Findings Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
| Official Action Indicated (OAI) |
| Jun 18, 2021 | Drugs · Drug Quality Assurance | 7 cited references- 21 CFR 211.137(a). Expiration date lacking Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
- 21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
- 21 CFR 211.56(a). Sanitation--buildings not clean, free of infestation Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
- 21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
- 21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size and suitably located to facilitate operations for its intended use.
- 21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in the particular operations they perform as part of their function and current good manufacturing practices.
- 21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
| Voluntary Action Indicated (VAI) |
| Mar 12, 2020 | Drugs · Drug Quality Assurance | 11 cited references- 21 CFR 211.28(d). Excluding Employees with Illness, Lesions Employees with apparent illness are not excluded from direct contact with components, drug product containers, closures and drug products until the condition is determined by competent medical personnel not to jeopardize the safety or quality of drug products.
- 21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
- 21 CFR 211.134(b). Representative samples after completion Samples of representative units were not collected and visually examined for correct labeling at the completion of finishing operations.
- 21 CFR 211.56(a). Sanitation--buildings not clean, free of infestation Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
- 21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size and suitably located to facilitate operations for its intended use.
- 21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
- 21 CFR 211.130(e). Packaging line inspection before use Inspection of the packaging and labeling facilities immediately before use is not done to assure that all drug products have been removed from previous operations.
- 21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
- 21 CFR 211.22(a). Lack of quality control unit There is no quality control unit.
- 21 CFR 211.125(f). Procedures Written and Followed Procedures describing in sufficient detail the controls employed for the issuance of labeling are not written and followed.
- 21 CFR 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
| Official Action Indicated (OAI) |
| Aug 1, 2013 | Drugs · Drug Quality Assurance | 5 cited references- 21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size, and suitably located to facilitate operations for its intended use.
- 21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
- 21 CFR 211.67(b). Written procedures fail to include Written procedures for cleaning and maintenance fail to include maintenance and cleaning schedules.
- 21 CFR 211.180(e)(2). Items to cover on annual reviews Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product.
- 21 CFR 211.125(a). Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.
| Voluntary Action Indicated (VAI) |
| May 20, 2011 | Drugs · Drug Quality Assurance | 3 cited references- 21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations.
- 21 CFR 211.100(a). Approval and review of procedures Written procedures are not reviewed and approved by the quality control unit.
- 21 CFR 211.180(e). Records reviewed annually Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
| Voluntary Action Indicated (VAI) |
| Jul 24, 2009 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
Albuquerque, New Mexico, United States. Part of