Drug factory · FDA FEI 3005444934

Sigmapharm Laboratories, LLC

3375 Progress Drive, Bensalem, PA, 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 17, 2025 inspection

• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other drug products that may have been associated with the specific failure or discrepancy.

Jun 19, 2017 inspection

• Review of representative number of batches 21 CFR 211.180(e)(1)
  Written procedures are not established for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.

Nov 19, 2014 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  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.
• 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 each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release.
• Annual visual exams of drug products 21 CFR 211.170(b)
  Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
• Maintenance of Complaint File 21 CFR 211.198(b)
  Complaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints.
• Approve or reject procedures or specs 21 CFR 211.22(c)
  The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality, and purity of drug products.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  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.

Aug 13, 2013 inspection

• Failure to review ADE information 21 CFR 314.80(b)
  Adverse drug experience information obtained or otherwise received from any source was not reviewed, including information from reports in the scientific literature and unpublished scientific papers.
• Incomplete periodic safety report 21 CFR 314.80(c)(2)(ii)(A)
  Not all periodic reports contained an FDA Form 3500A for each adverse drug experience not reported as a post marketing 15-day Alert report.

Registered with FDA for: analysis; api manufacture; manufacture.