Drug factory · FDA FEI 1218914

Safecor Health, LLC

317 N. Boston St., Suite 100, Woburn, 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 28, 2025 inspection

• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.

Jun 24, 2024 inspection

• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not 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.
• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.

Mar 16, 2023 inspection

• Packaging line inspection before use 21 CFR 211.130(e)
  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.
• Packaging line inspection before use 21 CFR 211.130(e)
  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.
• Master production and control records, procedure 21 CFR 211.186(a)
  The preparation of your master production and control records was not followed in accordance with your written procedure.
• Master production and control records, procedure 21 CFR 211.186(a)
  The preparation of your master production and control records was not followed in accordance with your written procedure.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
• Complaint Investigation/Follow-Up Findings 21 CFR 211.198(b)(2)
  Complaint records are deficient in that they do not include the findings of the follow-up.
• Complaint Investigation/Follow-Up Findings 21 CFR 211.198(b)(2)
  Complaint records are deficient in that they do not include the findings of the follow-up.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
  Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
• Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
  Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

Oct 19, 2017 inspection

• Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
  Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit.
• Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
  Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit.
• Acceptance criteria for sampling & testing 21 CFR 211.165(d)
  Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet as a condition for their approval and release.
• Acceptance criteria for sampling & testing 21 CFR 211.165(d)
  Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet as a condition for their approval and release.
• Review of representative number of batches 21 CFR 211.180(e)(1)
  Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
• Review of representative number of batches 21 CFR 211.180(e)(1)
  Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
• Reporting of adverse drug experience to FDA 21 CFR 211.198(a)
  Written procedures describing the handling of all written and oral complaints do not include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration.
• Reporting of adverse drug experience to FDA 21 CFR 211.198(a)
  Written procedures describing the handling of all written and oral complaints do not include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over humidity and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over humidity and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
• Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
  Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
• Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
  Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

Registered with FDA for: manufacture; pack; relabel; repack.