Drug factory · FDA FEI 1215362

Medical-technical Gases, Inc.

8 Executive Park Dr, North Billerica, MA, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Oct 12, 2023 inspection

• Labeling Control Records and Label Copies 21 CFR 211.188(b)(8)
  The batch production and control records are deficient in that they do not include specimen and copy of labeling.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

Jul 8, 2022 inspection

• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
• Strict control not exercised over labeling issued 21 CFR 211.125(a)
  Strict control is not exercised over labeling issued for use in drug product labeling operations.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established laboratory control mechanisms are not followed.
• Test methods 21 CFR 211.165(e)
  The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
• Lack of written stability program 21 CFR 211.166(a)
  There is no written testing program designed to assess the stability characteristics of drug products.
• Labeling control records including specimens or copies 21 CFR 211.188(b)(8)
  Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are not written or followed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration, inspection and checking of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.
• Backup file not maintained 21 CFR 211.68(b)
  Failure to maintain a backup file of data entered into the computer or related system.

Aug 7, 2015 inspection

• Quality control unit review of records 21 CFR 211.192
  Drug product production and control records, are not reviewed by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
• Procedures to be written and followed 21 CFR 211.198(a)
  Procedures describing the handling of all written and oral complaints regarding a drug product are not followed .
• GMP Training Frequency 21 CFR 211.25(a)
  GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Registered with FDA for: manufacture.