Drug factory · FDA FEI 1032592

All Oxygen Refills, Inc.

4108 NW 135th Street, Opa Locka, FL, 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.

Dec 18, 2009 inspection

• Approval and review of procedures 21 CFR 211.100(a)
  Written procedures are not reviewed and approved by the quality control unit.
• 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.
• Sampling/testing of labeling/packaging materials 21 CFR 211.122(a)
  Labeling and packaging materials are not examined upon receipt and before use in packaging and labeling of a drug product.
• 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.
• Procedures Written and Followed 21 CFR 211.125(f)
  Procedures describing in sufficient detail the controls employed for the issuance of labeling are not written.
• Correct labels during finishing operations 21 CFR 211.134(a)
  Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the correct label.
• Quarantine - written procedures 21 CFR 211.142(a)
  Written procedures for the warehousing of drug products do not include quarantine of drug products before release by the quality control unit.
• Recall facilitation 21 CFR 211.150(b)
  A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary, has not been established.
• Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
  The calibration of instruments and gauges is not done at suitable intervals with provisions for remedial action in the event accuracy and/or precision limits are not met.
• Signature and checking of records -- 2 persons 21 CFR 211.186(a)
  The master production and control records for each batch size of drug product are not independently checked, dated, and signed by a second person.
• Prepared for each batch, include complete information 21 CFR 211.188
  Batch production and control records do not include complete information relating to the production and control of each batch.
• In-process and laboratory control results 21 CFR 211.188(b)(5)
  Batch production and control records do not include laboratory control results for each batch of drug product produced.
• 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 established.
• Lack of quality control unit 21 CFR 211.22(a)
  There is no quality control unit.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture of a drug product lack the training required to perform their assigned functions.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in written procedures required by current good manufacturing practice regulations.
• Written sanitation procedures lacking 21 CFR 211.56(b)
  There is a lack of written procedures providing cleaning schedules and describing in sufficient detail the methods, equipment and materials to be used for sanitation.
• Cleaning/maintenance records not kept 21 CFR 211.67(c)
  Records are not kept for the maintenance, cleaning, and inspection of equipment.

Registered with FDA for: manufacture.